A Phase 4 interventional study of Tenofovir Disoproxil Fumarate in Hepatitis B, Chronic, sponsored by GlaxoSmithKline. Completed at 18 sites in Japan. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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Among 50 studies testing tenofovir in Hepatitis B, Chronic — none open to participants now, 1 under way, 1 of them phase 3. Tenofovir · Hepatitis B, Chronic.
Among the 50 studies testing tenofovir in Hepatitis B, Chronic, this one is the 37th largest by enrollment, is one of 5 that started in 2017, is one of 22 in phase 4, and was the 43rd registered.
896 studies on the registry are indexed under Hepatitis B, Chronic; 153 are open to participants now.
Browse Hepatitis B, Chronic studies →None of the 50 studies testing tenofovir in Hepatitis B, Chronic is open now. The open studies under Hepatitis B, Chronic, anywhere →
Tenofovir: first FDA approval 2001 (VIREAD), first EMA approval 2002. What it is approved for, and how studies give it, is on its page →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 20 Years to 69 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 13 · Phase 4 22
First in 2004; this study’s year is marked. 5 started in 2017.
This study's enrollment of 75 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 117 across the 50 interventional studies. Of the 37 that completed or were terminated, 17 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 50 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
30 studies in Hepatitis B, Chronic by GlaxoSmithKline: 1 open now, 2 under way, none of them phase 3. Of 28 finished, 18 (64%) have results posted.
Among the 30 studies in Hepatitis B, Chronic by GlaxoSmithKline, this one is the 24th largest by enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 in phase 4, and was the 21st registered.
GlaxoSmithKline’s Hepatitis B, Chronic studies by the year they started, since 2000.
None of the studies under way reaches primary completion within a year.
Among the 50 studies testing tenofovir in Hepatitis B, Chronic, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 30 in Hepatitis B, Chronic:
This tab as a report to print or save as PDF → With an account.
Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in subjects with chronic hepatitis B associated with HBV growth and abnormal liver function. This study has been planned to evaluate the virological effects and safety of switching from ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV- deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center, one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV. After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects will be screened to achieve 65 evaluable subjects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male and female subjects. A female subject is eligible to participate if she is not pregnant and not breastfeeding, and at least one of the following conditions applies:
Meet either of the following serum HBsAg levels at screening:
Meet all of the following criteria at screening:
Male: CLcr = (body weight in kilogram [kg] multiplied by [140 minus age in years]) divided by (72 multiplied by serum creatinine [milligram {mg}/deciliter {dL}]) Female: CLcr = CLcr (male) multiplied by 0.85
Exclusion Criteria:
Received any of the following drugs within 8 weeks prior to initiation of the study treatment (excluding topical products such as ointment and/or cream etc).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with on-going ETV treatment will be switched to Tenofovir Disoproxil Fumarate treatment. Subjects will start TDF on the day ETV is discontinued, without having overlapping treatment periods. All subjects will receive one tablet of TDF 300 mg once daily orally for 96 weeks.
Drug: Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits HBV growth. All subjects will receive one tablet of TDF 300 mg once daily orally for 96 weeks.
Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48
Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were\<=-0.25 log10 and non-responder values were \>-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen \[HBcrAg\], HBeAg, hepatitis B surface antibody \[HBsAb\],Hepatitis B envelope antibody \[HBeAb\], alanine aminotransferase \[ALT\]) from at least 15 days after the start of study treatment. Data for HBsAg responders have been presented.
Time frame: Baseline (Day 1, Pre-dose) and at Week 48
Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96
Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Weeks 24 and 96. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responders have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 24 and 96
Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24, 48 and 96. A 'Loss' of HBsAg means antigen is negative. HBsAg loss percentage is defined as number of participants with HBsAg loss divided by number of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Weeks 24, 48 and 96
Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as number of participants with HBsAg/Ab Seroconversion divided by number of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Weeks 24, 48 and 96
Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24, 48 and 96. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Weeks 24, 48 and 96
Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as number of participants with HBeAg/Ab Seroconversion divided by number of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Weeks 24, 48 and 96
Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96
Blood samples were collected to evaluate the HBsAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96
Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96
Blood samples were collected to evaluate the HBcrAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96
Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment.
Time frame: Up to Week 96
Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)
Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein
Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH)
Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase
Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)
Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance
Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)
Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Percentage of Basophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented.
Time frame: At Weeks 36, 48, 60, 72, 84 and 96
Percentage of Eosinophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented.
Time frame: At Weeks 36 , 48, 60, 72, 84 and 96
Percentage of Lymphocytes at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented.
Time frame: At Weeks 36, 48, 60, 72, 84 and 96
Percentage of Monocytes at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented.
Time frame: At Weeks 36, 48, 60, 72, 84 and 96
Percentage of Total Neutrophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented.
Time frame: At Weeks 36, 48, 60, 72, 84 and 96
Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count
Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Hematology Parameter: Prothrombin Time
Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported.
Time frame: Weeks 4, 12, 24, 36 and 48
Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported.
Time frame: Weeks 60, 72, 84 and 96
Change From Baseline Values for Beta-2-microglobulin
Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate
Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Heart Rate
Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Absolute Values for Temperature
Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Up to Week 96
Change From Baseline Values for Bone Density
Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day -1) and at Weeks 24, 48, 72 and 96
This was a multi-center, single-arm study to assess efficacy and safety of tenofovir disoproxil fumarate (TDF) by switching at Day 1 from entecavir hydrate (ETV) to TDF in chronic hepatitis B envelope antigen (HBeAg)-positive and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) undetectable participants.
| Milestone | Tenofovir Disoproxil Fumarate |
|---|---|
| Started | 75 |
| Completed | 72 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol-defined stopping criteria | 1 |
| Withdrew: Physician decision | 1 |
Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were\<=-0.25 log10 and non-responder values were \>-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen \[HBcrAg\], HBeAg, hepatitis B surface antibody \[HBsAb\],Hepatitis B envelope antibody \[HBeAb\], alanine aminotransferase \[ALT\]) from at least 15 days after the start of study treatment. Data for HBsAg responders have been presented.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| <= -0.25 log10 | 4 (0.8 to 11.4) |
| > -0.25 log10 | 96 (88.6 to 99.2) |
Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Weeks 24 and 96. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responders have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24 | 1 (0.0 to 7.3) |
| Week 96 | 12 (5.7 to 21.8) |
Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24, 48 and 96. A 'Loss' of HBsAg means antigen is negative. HBsAg loss percentage is defined as number of participants with HBsAg loss divided by number of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24 | 0 |
| Week 48 | 0 |
| Week 96 | 0 |
Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as number of participants with HBsAg/Ab Seroconversion divided by number of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24 | 0 |
| Week 48 | 0 |
| Week 96 | 0 |
Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24, 48 and 96. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24 | 12 |
| Week 48 | 12 |
| Week 96 | 25 |
Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as number of participants with HBeAg/Ab Seroconversion divided by number of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Percentage of Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24 | 8 |
| Week 48 | 13 |
| Week 96 | 25 |
Blood samples were collected to evaluate the HBsAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
| Log Kilo International Units per Liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24, n=74 | -0.049 ± 0.0913 |
| Week 48, n=73 | -0.114 ± 0.0837 |
| Week 96, n=72 | -0.139 ± 0.1207 |
Blood samples were collected to evaluate the HBcrAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
| Log Kilounits per Liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 24, n=74 | -0.12 ± 0.232 |
| Week 48, n=73 | -0.17 ± 0.286 |
| Week 96, n=72 | -0.30 ± 0.360 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment.
| Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Any SAE | 2 |
| Any non-SAE | 36 |
Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Micrograms per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 3.13 ± 1.474 |
| Week 4, n=75 | 3.39 ± 1.507 |
| Week 12, n=74 | 3.46 ± 1.642 |
| Week 24, n=74 | 3.50 ± 1.597 |
| Week 36, n=73 | 3.48 ± 1.578 |
| Week 48, n=73 | 3.55 ± 1.693 |
| Week 60, n=73 | 3.50 ± 1.683 |
| Week 72, n=73 | 3.27 ± 1.499 |
| Week 84, n=72 | 3.10 ± 1.478 |
| Week 96, n=72 | 3.18 ± 1.537 |
Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Grams per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Albumin, Baseline (Day 1), n=75 | 44.7 ± 2.60 |
| Albumin, Week 4, n=75 | 44.9 ± 2.21 |
| Albumin, Week 12, n=74 | 45.2 ± 2.17 |
| Albumin, Week 24, n=74 | 44.5 ± 2.18 |
| Albumin, Week 36, n=73 | 44.2 ± 2.11 |
| Albumin, Week 48, n=73 | 44.8 ± 2.20 |
| Albumin, Week 60, n=73 | 45.1 ± 1.88 |
| Albumin, Week 72, n=73 | 44.9 ± 2.14 |
| Albumin, Week 84, n=72 | 44.6 ± 2.05 |
| Albumin, Week 96, n=72 | 45.4 ± 2.26 |
| Total protein, Baseline (Day 1) n=75 | 72.4 ± 4.28 |
| Total protein, Week 4, n=75 | 72.6 ± 3.81 |
| Total protein, Week 12, n=74 | 73.1 ± 3.93 |
| Total protein, Week 24, n=74 | 72.0 ± 3.86 |
| Total protein, Week 36, n=73 | 71.7 ± 3.76 |
| Total protein, Week 48, n=73 | 72.6 ± 4.12 |
| Total protein, Week 60, n=73 | 72.8 ± 4.08 |
| Total protein, Week 72, n=73 | 72.4 ± 4.32 |
| Total protein, Week 84, n=72 | 72.4 ± 4.35 |
| Total protein, Week 96, n=72 | 73.0 ± 4.07 |
Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| International units per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| ALP, Baseline (Day 1), n=75 | 210.4 ± 62.87 |
| ALP, Week 4, n=75 | 227.6 ± 70.27 |
| ALP, Week 12, n=74 | 243.1 ± 76.26 |
| ALP, Week 24, n=74 | 242.1 ± 77.76 |
| ALP, Week 36, n=73 | 245.3 ± 75.15 |
| ALP, Week 48, n=73 | 249.4 ± 73.17 |
| ALP, Week 60, n=73 | 253.1 ± 75.62 |
| ALP, Week 72, n=73 | 249.2 ± 72.56 |
| ALP, Week 84, n=72 | 237.6 ± 69.60 |
| ALP, Week 96, n=72 | 237.7 ± 72.92 |
| ALT, Baseline (Day 1), n=75 | 23.5 ± 18.13 |
| ALT, Week 4, n=75 | 28.3 ± 19.82 |
| ALT, Week 12, n=74 | 27.9 ± 16.48 |
| ALT, Week 24, n=74 | 27.5 ± 19.09 |
| ALT, Week 36, n=73 | 25.9 ± 14.70 |
| ALT, Week 48, n=73 | 27.0 ± 13.14 |
| ALT, Week 60, n=73 | 26.6 ± 12.65 |
| ALT, Week 72, n=73 | 24.2 ± 9.16 |
| ALT, Week 84, n=72 | 26.3 ± 20.75 |
| ALT, Week 96, n=72 | 26.4 ± 25.60 |
| AST, Baseline (Day 1), n=75 | 22.7 ± 8.80 |
| AST, Week 4, n=75 | 26.1 ± 8.70 |
| AST, Week 12, n=74 | 25.8 ± 8.34 |
| AST, Week 24, n=74 | 25.5 ± 9.31 |
| AST, Week 36, n=73 | 24.6 ± 7.88 |
| AST, Week 48, n=73 | 25.7 ± 7.58 |
| AST, Week 60, n=73 | 25.1 ± 6.23 |
| AST, Week 72, n=73 | 24.1 ± 5.25 |
| AST, Week 84, n=72 | 25.0 ± 10.38 |
| AST, Week 96, n=72 | 24.9 ± 12.03 |
| CPK, Baseline (Day 1), n=75 | 138.9 ± 100.01 |
| CPK, Week 4, n=75 | 151.0 ± 113.92 |
| CPK, Week 12, n=74 | 144.5 ± 148.47 |
| CPK, Week 24, n=74 | 127.9 ± 56.20 |
| CPK, Week 36, n=73 | 131.9 ± 79.25 |
| CPK, Week 48, n=73 | 148.7 ± 106.89 |
| CKP, Week 60, n=73 | 134.1 ± 65.76 |
| CKP, Week 72, n=73 | 143.3 ± 81.86 |
| CKP, Week 84, n=72 | 127.4 ± 60.37 |
| CKP, Week 96, n=72 | 132.3 ± 67.94 |
| GGT, Baseline (Day 1), n=75 | 30.9 ± 24.23 |
| GGT, Week 4, n=75 | 31.6 ± 27.23 |
| GGT, Week 12, n=74 | 31.5 ± 31.14 |
| GGT, Week 24, n=74 | 30.4 ± 28.57 |
| GGT, Week 36, n=73 | 27.6 ± 24.30 |
| GGT, Week 48, n=73 | 27.8 ± 22.60 |
| GGT, Week 60, n=73 | 28.2 ± 24.67 |
| GGT, Week 72, n=73 | 25.6 ± 16.94 |
| GGT, Week 84, n=72 | 27.4 ± 25.22 |
| GGT, Week 96, n=72 | 27.8 ± 23.75 |
| LDH, Baseline (Day 1), n=75 | 165.2 ± 30.53 |
| LDH, Week 4, n=75 | 173.9 ± 35.23 |
| LDH, Week 12, n=74 | 171.0 ± 32.19 |
| LDH, Week 24, n=74 | 169.4 ± 28.94 |
| LDH, Week 36, n=73 | 170.3 ± 28.91 |
| LDH, Week 48, n=73 | 175.3 ± 33.33 |
| LDH, Week 60, n=73 | 174.4 ± 33.12 |
| LDH, Week 72, n=73 | 174.6 ± 32.97 |
| LDH, Week 84, n=72 | 172.7 ± 34.58 |
| LDH, Week 96, n=72 | 173.2 ± 34.08 |
Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Units per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Amylase, Baseline (Day 1), n=75 | 87.3 ± 26.00 |
| Amylase, Week 4, n=75 | 89.5 ± 24.99 |
| Amylase, Week 12, n=74 | 88.2 ± 26.21 |
| Amylase, Week 24, n=74 | 83.7 ± 23.30 |
| Amylase, Week 36, n=73 | 82.3 ± 24.29 |
| Amylase, Week 48, n=73 | 84.9 ± 26.08 |
| Amylase, Week 60, n=73 | 92.2 ± 32.20 |
| Amylase, Week 72, n=73 | 88.8 ± 27.87 |
| Amylase, Week 84, n=72 | 84.4 ± 24.93 |
| Amylase, Week 96, n=72 | 86.7 ± 32.31 |
| Lipase, Baseline (Day 1), n=75 | 40.0 ± 17.99 |
| Lipase, Week 4, n=75 | 41.9 ± 14.27 |
| Lipase, Week 12, n=74 | 39.1 ± 13.97 |
| Lipase, Week 24, n=74 | 36.0 ± 9.95 |
| Lipase, Week 36, n=73 | 36.9 ± 12.64 |
| Lipase, Week 48, n=73 | 36.2 ± 12.91 |
| Lipase, Week 60, n=73 | 39.1 ± 13.07 |
| Lipase, Week 72, n=73 | 37.1 ± 13.72 |
| Lipase, Week 84, n=72 | 33.5 ± 11.55 |
| Lipase, Week 96, n=72 | 34.2 ± 16.73 |
Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Micromoles per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Direct bilirubin, Baseline (Day 1), n=75 | 3.899 ± 2.0574 |
| Direct bilirubin, Week 4, n=75 | 3.944 ± 1.6386 |
| Direct bilirubin, Week 12, n=74 | 3.928 ± 1.5943 |
| Direct bilirubin, Week 24, n=74 | 4.021 ± 1.9493 |
| Direct bilirubin, Week 36, n=73 | 3.959 ± 1.9304 |
| Direct bilirubin, Week 48, n=73 | 4.029 ± 2.1015 |
| Direct bilirubin, Week 60, n=73 | 3.607 ± 1.4409 |
| Direct bilirubin, Week 72, n=73 | 3.959 ± 1.7540 |
| Direct bilirubin, Week 84, n=72 | 3.919 ± 1.7560 |
| Direct bilirubin, Week 96, n=72 | 4.418 ± 1.8765 |
| Total bilirubin, Baseline (Day 1), n=75 | 10.693 ± 5.4663 |
| Total bilirubin, Week 4, n=75 | 10.009 ± 4.1478 |
| Total bilirubin, Week 12, n=74 | 9.890 ± 4.1528 |
| Total bilirubin, Week 24, n=74 | 10.584 ± 5.4641 |
| Total bilirubin, Week 36, n=73 | 10.518 ± 5.2834 |
| Total bilirubin, Week 48, n=73 | 10.635 ± 5.6373 |
| Total bilirubin, Week 60, n=73 | 9.557 ± 3.7684 |
| Total bilirubin, Week 72, n=73 | 10.237 ± 5.0381 |
| Total bilirubin, Week 84, n=72 | 10.284 ± 5.9340 |
| Total bilirubin, Week 96, n=72 | 11.329 ± 4.4037 |
| Creatinine, Baseline (Day 1), n=75 | 62.9997 ± 11.33874 |
| Creatinine, Week 4, n=75 | 64.1666 ± 11.28624 |
| Creatinine, Week 12, n=74 | 65.8102 ± 10.95564 |
| Creatinine, Week 24, n=74 | 65.2965 ± 11.04922 |
| Creatinine, Week 36, n=73 | 65.9852 ± 10.57867 |
| Creatinine, Week 48, n=73 | 65.9125 ± 11.31592 |
| Creatinine, Week 60, n=73 | 65.3191 ± 10.70634 |
| Creatinine, Week 72, n=73 | 65.4887 ± 11.06350 |
| Creatinine, Week 84, n=72 | 66.5578 ± 11.42181 |
| Creatinine, Week 96, n=72 | 67.3436 ± 11.07035 |
| Uric acid, Baseline (Day 1), n=75 | 333.0880 ± 71.24862 |
| Uric acid, Week 4, n=75 | 322.9367 ± 67.10023 |
| Uric acid, Week 12, n=74 | 323.3622 ± 73.51388 |
| Uric acid, Week 24, n=74 | 321.3528 ± 70.76893 |
| Uric acid, Week 36, n=73 | 320.9476 ± 70.10092 |
| Uric acid, Week 48, n=73 | 320.8661 ± 67.21277 |
| Uric acid, Week 60, n=73 | 309.3775 ± 62.83437 |
| Uric acid, Week 72, n=73 | 318.0958 ± 71.99367 |
| Uric acid, Week 84, n=72 | 318.0528 ± 66.72860 |
| Uric acid, Week 96, n=72 | 328.0487 ± 71.10783 |
Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Millimoles per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Calcium, Baseline (Day 1), n=75 | 2.290743 ± 0.0712447 |
| Calcium, Week 4, n=75 | 2.272446 ± 0.0650823 |
| Calcium, Week 12, n=74 | 2.265393 ± 0.0642412 |
| Calcium, Week 24, n=74 | 2.251232 ± 0.0711166 |
| Calcium, Week 36, n=73 | 2.257121 ± 0.0674474 |
| Calcium, Week 48, n=73 | 2.297792 ± 0.0662944 |
| Calcium, Week 60, n=73 | 2.316932 ± 0.0668335 |
| Calcium, Week 72, n=73 | 2.297451 ± 0.0711492 |
| Calcium, Week 84, n=72 | 2.289856 ± 0.0621422 |
| Calcium, Week 96, n=72 | 2.306489 ± 0.0685384 |
| Chloride, Baseline (Day 1), n=75 | 103.5 ± 2.09 |
| Chloride, Week 4, n=75 | 103.3 ± 1.90 |
| Chloride, Week 12, n=74 | 103.5 ± 2.04 |
| Chloride, Week 24, n=74 | 103.9 ± 1.70 |
| Chloride, Week 36, n=73 | 104.0 ± 1.98 |
| Chloride, Week 48, n=73 | 103.6 ± 1.87 |
| Chloride, Week 60, n=73 | 103.6 ± 1.85 |
| Chloride, Week 72, n=73 | 104.1 ± 2.16 |
| Chloride, Week 84, n=72 | 104.9 ± 2.40 |
| Chloride, Week 96, n=72 | 104.3 ± 2.01 |
| Glucose, Baseline (Day 1), n=75 | 5.832251 ± 1.3417805 |
| Glucose, Week 4, n=75 | 5.704208 ± 1.0439295 |
| Glucose, Week 12, n=74 | 5.590757 ± 0.8796367 |
| Glucose, Week 24, n=74 | 5.652268 ± 0.9310549 |
| Glucose, Week 36, n=73 | 5.582937 ± 1.0191927 |
| Glucose, Week 48, n=73 | 5.709165 ± 0.8209347 |
| Glucose, Week 60, n=73 | 5.887862 ± 1.1524669 |
| Glucose, Week 72, n=73 | 5.801175 ± 0.9035958 |
| Glucose, Week 84, n=72 | 5.938799 ± 1.0721973 |
| Glucose, Week 96, n=72 | 5.544061 ± 0.6818280 |
| Potassium, Baseline (Day 1), n=75 | 4.07 ± 0.258 |
| Potassium, Week 4, n=75 | 4.07 ± 0.254 |
| Potassium, Week 12, n=74 | 4.04 ± 0.257 |
| Potassium, Week 24, n=74 | 4.03 ± 0.236 |
| Potassium, Week 36, n=73 | 4.02 ± 0.264 |
| Potassium, Week 48, n=73 | 4.05 ± 0.249 |
| Potassium, Week 60, n=73 | 4.09 ± 0.275 |
| Potassium, Week 72, n=73 | 4.10 ± 0.288 |
| Potassium, Week 84, n=72 | 4.03 ± 0.260 |
| Potassium, Week 96, n=72 | 4.05 ± 0.233 |
| Lactic acid, Baseline (Day 1), n=75 | 1.10467 ± 0.397387 |
| Lactic acid, Week 4, n=75 | 1.02342 ± 0.378255 |
| Lactic acid, Week 12, n=74 | 1.07535 ± 0.464637 |
| Lactic acid, Week 24, n=74 | 1.04970 ± 0.401795 |
| Lactic acid, Week 36, n=73 | 1.06089 ± 0.434265 |
| Lactic acid, Week 48, n=73 | 1.02865 ± 0.413619 |
| Lactic acid, Week 60, n=73 | 1.15182 ± 0.466672 |
| Lactic acid, Week 72, n=73 | 1.06332 ± 0.375955 |
| Lactic acid, Week 84, n=72 | 1.12526 ± 0.493101 |
| Lactic acid, Week 96, n=72 | 0.93703 ± 0.400024 |
| Sodium, Baseline (Day 1), n=75 | 141.6 ± 1.64 |
| Sodium, Week 4, n=75 | 141.9 ± 1.61 |
| Sodium, Week 12, n=74 | 142.3 ± 1.45 |
| Sodium, Week 24, n=74 | 142.2 ± 1.32 |
| Sodium, Week 36, n=73 | 142.0 ± 1.52 |
| Sodium, Week 48, n=73 | 142.0 ± 1.45 |
| Sodium, Week 60, n=73 | 142.2 ± 1.55 |
| Sodium, Week 72, n=73 | 142.0 ± 1.26 |
| Sodium, Week 84, n=72 | 142.0 ± 1.74 |
| Sodium, Week 96, n=72 | 141.3 ± 1.43 |
| Phosphorus inorganic, Baseline (Day 1), n=75 | 1.072028 ± 0.1757407 |
| Phosphorus inorganic, Week 4, n=75 | 1.031558 ± 0.1563869 |
| Phosphorus inorganic, Week 12, n=74 | 1.061206 ± 0.1621407 |
| Phosphorus inorganic, Week 24, n=74 | 1.052479 ± 0.1695973 |
| Phosphorus inorganic, Week 36, n=73 | 1.061589 ± 0.1529705 |
| Phosphorus inorganic, Week 48, n=73 | 1.073090 ± 0.1642529 |
| Phosphorus inorganic, Week 60, n=73 | 1.071320 ± 0.1738322 |
| Phosphorus inorganic, Week 72, n=73 | 1.082378 ± 0.1734792 |
| Phosphorus inorganic, Week 84, n=72 | 1.070952 ± 0.1739292 |
| Phosphorus inorganic, Week 96, n=72 | 1.095169 ± 0.1397279 |
| BUN, Baseline (Day 1), n=75 | 4.89518 ± 1.278805 |
| BUN, Week 4, n=75 | 4.80712 ± 1.270529 |
| BUN, Week 12, n=74 | 4.86581 ± 1.389805 |
| BUN, Week 24, n=74 | 4.96519 ± 1.315155 |
| BUN, Week 36, n=73 | 4.86449 ± 1.433234 |
| BUN, Week 48, n=73 | 4.71289 ± 1.240093 |
| BUN, Week 60, n=73 | 4.84884 ± 1.312435 |
| BUN, Week 72, n=73 | 4.86889 ± 1.090615 |
| BUN, Week 84, n=72 | 4.70000 ± 1.441539 |
| BUN, Week 96, n=72 | 4.65389 ± 1.214425 |
Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Milliliters per minute | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 114.06 ± 23.849 |
| Week 4, n=75 | 112.50 ± 25.283 |
| Week 12, n=74 | 108.76 ± 24.634 |
| Week 24, n=74 | 108.86 ± 24.963 |
| Week 36, n=73 | 105.23 ± 23.739 |
| Week 48, n=73 | 105.50 ± 24.333 |
| Week 60, n=73 | 107.51 ± 25.719 |
| Week 72, n=73 | 106.73 ± 24.278 |
| Week 84, n=72 | 104.00 ± 23.511 |
| Week 96, n=72 | 101.47 ± 23.705 |
Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Milliliters per second per 1.73*meter^2 | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 1.46981 ± 0.260068 |
| Week 4, n=75 | 1.43825 ± 0.260661 |
| Week 12, n=74 | 1.39282 ± 0.241198 |
| Week 24, n=74 | 1.40228 ± 0.238776 |
| Week 36, n=73 | 1.37971 ± 0.235498 |
| Week 48, n=73 | 1.38564 ± 0.250919 |
| Week 60, n=73 | 1.39501 ± 0.246331 |
| Week 72, n=73 | 1.38998 ± 0.243750 |
| Week 84, n=72 | 1.36299 ± 0.233140 |
| Week 96, n=72 | 1.34355 ± 0.239422 |
Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented.
| Percentage of basophils | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 36, n=32 | 0.46 ± 0.240 |
| Week 48, n=73 | 0.49 ± 0.303 |
| Week 60, n=73 | 0.57 ± 0.453 |
| Week 72, n=73 | 0.50 ± 0.319 |
| Week 84, n=72 | 0.54 ± 0.305 |
| Week 96, n=72 | 0.57 ± 0.376 |
Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented.
| Percentage of eosinophils | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 36, n=32 | 2.44 ± 1.767 |
| Week 48, n=73 | 2.94 ± 2.667 |
| Week 60, n=73 | 2.85 ± 2.298 |
| Week 72, n=73 | 3.09 ± 2.519 |
| Week 84, n=72 | 2.84 ± 2.042 |
| Week 96, n=72 | 2.57 ± 2.145 |
Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented.
| Percentage of lymphocytes | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 36, n=32 | 33.34 ± 8.858 |
| Week 48, n=73 | 32.39 ± 8.516 |
| Week 60, n=73 | 32.73 ± 7.541 |
| Week 72, n=73 | 32.29 ± 8.579 |
| Week 84, n=72 | 31.94 ± 7.424 |
| Week 96, n=72 | 32.98 ± 8.215 |
Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented.
| Percentage of monocytes | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 36, n=32 | 5.30 ± 1.492 |
| Week 48, n=73 | 5.46 ± 1.598 |
| Week 60, n=73 | 5.65 ± 1.430 |
| Week 72, n=73 | 5.67 ± 1.814 |
| Week 84, n=72 | 5.71 ± 1.562 |
| Week 96, n=72 | 5.45 ± 1.475 |
Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented.
| Percentage of neutrophils | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 36, n=32 | 58.46 ± 8.658 |
| Week 48, n=73 | 58.72 ± 8.709 |
| Week 60, n=73 | 58.20 ± 8.176 |
| Week 72, n=73 | 58.45 ± 9.109 |
| Week 84, n=72 | 58.97 ± 7.881 |
| Week 96, n=72 | 58.43 ± 8.973 |
Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Grams per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 148.2 ± 13.13 |
| Week 4, n=75 | 148.9 ± 13.40 |
| Week 12, n=74 | 148.4 ± 14.41 |
| Week 24, n=74 | 146.3 ± 14.28 |
| Week 36, n=73 | 144.1 ± 15.58 |
| Week 48, n=73 | 146.5 ± 15.81 |
| Week 60, n=73 | 147.1 ± 14.93 |
| Week 72, n=73 | 146.4 ± 14.95 |
| Week 84, n=72 | 144.6 ± 16.01 |
| Week 96, n=72 | 146.4 ± 16.07 |
Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Proportion of red blood cells in blood | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 0.4393 ± 0.03331 |
| Week 4, n=75 | 0.4441 ± 0.03475 |
| Week 12, n=74 | 0.4452 ± 0.03679 |
| Week 24, n=74 | 0.4367 ± 0.03550 |
| Week 36, n=73 | 0.4283 ± 0.04156 |
| Week 48, n=73 | 0.4350 ± 0.03942 |
| Week 60, n=73 | 0.4398 ± 0.03940 |
| Week 72, n=73 | 0.4391 ± 0.03817 |
| Week 84, n=72 | 0.4339 ± 0.04070 |
| Week 96, n=72 | 0.4355 ± 0.04159 |
Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Giga cells per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Platelet count, Baseline (Day 1), n=75 | 226.7 ± 53.40 |
| Platelet count, Week 4, n=75 | 227.1 ± 57.44 |
| Platelet count, Week 12, n=74 | 228.9 ± 57.67 |
| Platelet count, Week 24, n=74 | 226.1 ± 55.46 |
| Platelet count, Week 36, n=73 | 231.4 ± 65.32 |
| Platelet count, Week 48, n=73 | 229.9 ± 57.37 |
| Platelet count, Week 60, n=73 | 231.8 ± 56.11 |
| Platelet count, Week 72, n=73 | 224.9 ± 53.00 |
| Platelet count, Week 84, n=72 | 224.8 ± 57.64 |
| Platelet count, Week 96, n=72 | 226.6 ± 54.72 |
| WBC count, Baseline (Day 1), n=75 | 5.18 ± 1.558 |
| WBC count, Week 4, n=75 | 5.21 ± 1.525 |
| WBC count, Week 12, n=74 | 5.30 ± 1.380 |
| WBC count, Week 24, n=74 | 5.06 ± 1.279 |
| WBC count, Week 36, n=73 | 4.99 ± 1.320 |
| WBC count, Week 48, n=73 | 5.16 ± 1.674 |
| WBC count, Week 60, n=73 | 4.84 ± 1.247 |
| WBC count, Week 72, n=73 | 5.00 ± 1.372 |
| WBC count, Week 84, n=72 | 5.00 ± 1.338 |
| WBC count, Week 96, n=72 | 5.08 ± 1.583 |
Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Seconds | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 11.82 ± 0.632 |
| Week 4, n=75 | 11.91 ± 0.679 |
| Week 12, n=74 | 11.95 ± 0.642 |
| Week 24, n=74 | 11.76 ± 0.627 |
| Week 36, n=73 | 11.94 ± 0.720 |
| Week 48, n=73 | 12.71 ± 0.681 |
| Week 60, n=73 | 12.32 ± 0.613 |
| Week 72, n=73 | 12.40 ± 0.615 |
| Week 84, n=72 | 12.58 ± 0.684 |
| Week 96, n=72 | 12.78 ± 0.766 |
Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Trillion cells per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 4.785 ± 0.4087 |
| Week 4, n=75 | 4.841 ± 0.4154 |
| Week 12, n=74 | 4.865 ± 0.4358 |
| Week 24, n=74 | 4.820 ± 0.4061 |
| Week 36, n=73 | 4.704 ± 0.4473 |
| Week 48, n=73 | 4.780 ± 0.4026 |
| Week 60, n=73 | 4.819 ± 0.4288 |
| Week 72, n=73 | 4.793 ± 0.4058 |
| Week 84, n=72 | 4.757 ± 0.4314 |
| Week 96, n=72 | 4.777 ± 0.4440 |
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported.
| Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Amorphous phosphate crystals, Week 4, 1+ | 2 |
| Amorphous phosphate crystals, Week 12, 1+ | 2 |
| Amorphous phosphate crystals, Week 24, 1+ | 3 |
| Amorphous phosphate crystals, Week 36, 1+ | 2 |
| Amorphous phosphate crystals, Week 48, 1+ | 2 |
| Amorphous urate crystals, Week 4, 1+ | 3 |
| Amorphous urate crystals, Week 12, 1+ | 6 |
| Amorphous urate crystals, Week 24, 1+ | 8 |
| Amorphous urate crystals, Week 36, 1+ | 5 |
| Amorphous urate crystals, Week 48, 1+ | 5 |
| Bacteria, Week 4, 1+ | 5 |
| Bacteria, Week 12, 1+ | 11 |
| Bacteria, Week 24, 1+ | 6 |
| Bacteria, Week 24, 2+ | 2 |
| Bacteria, Week 36, 1+ | 8 |
| Bacteria, Week 48, 1+ | 11 |
| Bacteria, Week 48, 2+ | 1 |
| Calcium oxalate crystals, Week 4, 1+ | 11 |
| Calcium oxalate crystals, Week 12, 1+ | 9 |
| Calcium oxalate crystals, Week 24, 1+ | 14 |
| Calcium oxalate crystals, Week 36, 1+ | 15 |
| Calcium oxalate crystals, Week 48, 1+ | 10 |
| RTEC, Week 4, 0-0.1/Some Field | 23 |
| RTEC, Week 4, 0.2-0.4/Some Field | 5 |
| RTEC, Week 4, 1-2/Every Field | 1 |
| RTEC, Week 12, 0-0.1/Some Field | 25 |
| RTEC, Week 12, 0.2-0.4/Some Field | 4 |
| RTEC, Week 24, 0-0.1/Some Field | 19 |
| RTEC, Week 24, 0.2-0.4/Some Field | 2 |
| RTEC, Week 24, 1-2/Every Field | 1 |
| RTEC, Week 36, 0-0.1/Some Field | 19 |
| RTEC, Week 36, 0.2-0.4/Some Field | 2 |
| RTEC, Week 36, 1-2/Every Field | 1 |
| RTEC, Week 48, 0-0.1/Some Field | 21 |
| RTEC, Week 48, 0.2-0.4/Some Field | 5 |
| RTEC, Week 48, 1-2/Every Field | 3 |
| Fungi, Week 4, 1+ | 0 |
| Fungi, Week 12, 1+ | 0 |
| Fungi, Week 24, 1+ | 1 |
| Fungi, Week 36, 1+ | 0 |
| Fungi, Week 48, 1+ | 0 |
| Urine glucose, Week 4, 1+ | 1 |
| Urine glucose, Week 4, Trace | 1 |
| Urine glucose, Week 12, 2+ | 1 |
| Urine glucose, Week 12, Trace | 1 |
| Urine glucose, Week 24, 3+ | 1 |
| Urine glucose, Week 36, Trace | 2 |
| Urine glucose, Week 48, 1+ | 1 |
| Urine glucose, Week 48, 3+ | 1 |
| Urine glucose, Week 48, Trace | 1 |
| Hyaline casts, Week 4, 0-0.1/Some Field | 6 |
| Hyaline casts, Week 12, 0-0.1/Some Field | 3 |
| Hyaline casts, Week 12, 3-5/Whole Field | 2 |
| Hyaline casts, Week 24, 0-0.1/Some Field | 1 |
| Hyaline casts, Week 24, 1-2/Whole Field | 3 |
| Hyaline casts, Week 24, 3-5/Whole Field | 1 |
| Hyaline casts, Week 36, 0-0.1/Some Field | 1 |
| Hyaline casts, Week 36, 0.2-0.4/Some Field | 1 |
| Hyaline casts, Week 36, 1-2/Every Field | 1 |
| Hyaline casts, Week 36, 1-2/Whole Field | 1 |
| Hyaline casts, Week 48, 0-0.1/Some Field | 3 |
| Hyaline casts, Week 48, 0.2-0.4/Some Field | 1 |
| Mucus threads, Week 4, 1+ | 17 |
| Mucus threads, Week 12, 1+ | 21 |
| Mucus threads, Week 24, 1+ | 23 |
| Mucus threads, Week 36, 1+ | 25 |
| Mucus threads, Week 48, 1+ | 22 |
| Urine protein, Week 4, 1+ | 1 |
| Urine protein, Week 4, 2+ | 1 |
| Urine protein, Week 4, Trace | 15 |
| Urine protein, Week 12, 1+ | 2 |
| Urine protein, Week 12, Trace | 24 |
| Urine protein, Week 24, 1+ | 4 |
| Urine protein, Week 24, 2+ | 1 |
| Urine protein, Week 24, Trace | 28 |
| Urine protein, Week 36, 1+ | 3 |
| Urine protein, Week 36, 2+ | 1 |
| Urine protein, Week 36, Trace | 27 |
| Urine protein, Week 48, Trace | 15 |
| RBC, Week 4, 0-0.1/Some Field | 35 |
| RBC, Week 4, 0.2-0.4/Some Field | 20 |
| RBC, Week 4, 1-2/Every Field | 13 |
| RBC, Week 4, 3-5/Every Field | 4 |
| RBC, Week 4, 6-10/Every Field | 3 |
| RBC, Week 12, numerous/Every Field | 1 |
| RBC, Week 12, 0-0.1/Some Field | 33 |
| RBC, Week 12, 0.2-0.4/Some Field | 23 |
| RBC, Week 12, 1-2/Every Field | 11 |
| RBC, Week 12, 3-5/Every Field | 4 |
| RBC, Week 12, 6-10/Every Field | 1 |
| RBC, Week 12, 10-20/Every Field | 1 |
| RBC, Week 24, 0-0.1/Some Field | 40 |
| RBC, Week 24, 0.2-0.4/Some Field | 14 |
| RBC, Week 24, 1-2/Every Field | 14 |
| RBC, Week 24, 3-5/Every Field | 1 |
| RBC, Week 24, 6-10/Every Field | 2 |
| RBC, Week 24, 10-20/Every Field | 1 |
| RBC, Week 24, 20-30/Every Field | 2 |
| RBC, Week 36, 0-0.1/Some Field | 42 |
| RBC, Week 36, 0.2-0.4/Some Field | 20 |
| RBC, Week 36, 1-2/Every Field | 7 |
| RBC, Week 36, 3-5/Every Field | 1 |
| RBC, Week 36, 6-10/Every Field | 2 |
| RBC, Week 36, 10-20/Every Field | 1 |
| RBC, Week 48, 0-0.1/Some Field | 39 |
| RBC, Week 48, 0.2-0.4/Some Field | 14 |
| RBC, Week 48, 1-2/Every Field | 14 |
| RBC, Week 48, 3-5/Every Field | 3 |
| RBC, Week 48, 6-10/Every Field | 2 |
| RBC, Week 48, 10-20/Every Field | 1 |
| Spermatozoa, Week 4, 1+ | 1 |
| Spermatozoa, Week 12, 1+ | 0 |
| Spermatozoa, Week 24, 1+ | 2 |
| Spermatozoa, Week 36, 1+ | 3 |
| Spermatozoa, Week 48, 1+ | 0 |
| SEC, Week 4, 0-0.1/Some Field | 58 |
| SEC, Week 4, 0.2-0.4/Some Field | 7 |
| SEC, Week 4, 1-2/Every Field | 7 |
| SEC, Week 4, 3-5/Every Field | 2 |
| SEC, Week 4, 10-20/Every Field | 1 |
| SEC, Week 12, 0-0.1/Some Field | 54 |
| SEC, Week 12, 0.2-0.4/Some Field | 9 |
| SEC, Week 12, 1-2/Every Field | 6 |
| SEC, Week 12, 3-5/Every Field | 2 |
| SEC, Week 12, 6-10/Every Field | 1 |
| SEC, Week 12, 10-20/Every Field | 1 |
| SEC, Week 12, 30-50/Every Field | 1 |
| SEC, Week 24, 0-0.1/Some Field | 55 |
| SEC, Week 24, 0.2-0.4/Some Field | 6 |
| SEC, Week 24, 1-2/Every Field | 8 |
| SEC, Week 24, 3-5/Every Field | 1 |
| SEC, Week 24, 6-10/Every Field | 1 |
| SEC, Week 24, 10-20/Every Field | 2 |
| SEC, Week 24, 20-30/Every Field | 1 |
| SEC, Week 36, 0-0.1/Some Field | 59 |
| SEC, Week 36, 0.2-0.4/Some Field | 4 |
| SEC, Week 36, 1-2/Every Field | 9 |
| SEC, Week 36, 3-5/Every Field | 1 |
| SEC, Week 48, 0-0.1/Some Field | 58 |
| SEC, Week 48, 0.2-0.4/Some Field | 4 |
| SEC, Week 48, 1-2/Every Field | 5 |
| SEC, Week 48, 3-5/Every Field | 5 |
| SEC, Week 48, 6-10/Every Field | 1 |
| TEC, Week 4, 0-0.1/Some Field | 4 |
| TEC, Week 12, 0-0.1/Some Field | 4 |
| TEC, Week 24, 0-0.1/Some Field | 5 |
| TEC, Week 24, 0.2-0.4/Some Field | 2 |
| TEC, Week 36, 0-0.1/Some Field | 3 |
| TEC, Week 36, 0.2-0.4/Some Field | 1 |
| TEC, Week 36, 1-2/Every Field | 1 |
| TEC, Week 48, 0-0.1/Some Field | 5 |
| UAC, Week 4, 1+ | 0 |
| UAC, Week 12, 1+ | 0 |
| UAC, Week 24, 1+ | 0 |
| UAC, Week 36, 1+ | 2 |
| UAC, Week 48, 1+ | 1 |
| WBC, Week 4, 0-0.1/Some Field | 35 |
| WBC, Week 4, 0.2-0.4/Some Field | 27 |
| WBC, Week 4, 1-2/Every Field | 10 |
| WBC, Week 4, 3-5/Every Field | 1 |
| WBC, Week 4, 10-20/Every Field | 2 |
| WBC, Week 12, 0-0.1/Some Field | 37 |
| WBC, Week 12, 0.2-0.4/Some Field | 22 |
| WBC, Week 12, 1-2/Every Field | 8 |
| WBC, Week 12, 3-5/Every Field | 6 |
| WBC, Week 12, 6-10/Every Field | 1 |
| WBC, Week 24, 0-0.1/Some Field | 42 |
| WBC, Week 24, 0.2-0.4/Some Field | 20 |
| WBC, Week 24, 1-2/Every Field | 5 |
| WBC, Week 24, 3-5/Every Field | 3 |
| WBC, Week 24, 6-10/Every Field | 1 |
| WBC, Week 24, 10-20/Every Field | 2 |
| WBC, Week 24, 30-50/Every Field | 1 |
| WBC, Week 36, 0-0.1/Some Field | 45 |
| WBC, Week 36, 0.2-0.4/Some Field | 20 |
| WBC, Week 36, 1-2/Every Field | 1 |
| WBC, Week 36, 3-5/Every Field | 4 |
| WBC, Week 36, 6-10/Every Field | 2 |
| WBC, Week 36, 30-50/Every Field | 1 |
| WBC, Week 48, 0-0.1/Some Field | 43 |
| WBC, Week 48, 0.2-0.4/Some Field | 14 |
| WBC, Week 48, 1-2/Every Field | 11 |
| WBC, Week 48, 3-5/Every Field | 2 |
| WBC, Week 48, 6-10/Every Field | 2 |
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported.
| Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Amorphous phosphate crystals, Week 60, 1+ | 2 |
| Amorphous phosphate crystals, Week 72, 1+ | 2 |
| Amorphous phosphate crystals, Week 84, 1+ | 2 |
| Amorphous urate crystals, Week 60, 1+ | 3 |
| Amorphous urate crystals, Week 72, 1+ | 2 |
| Amorphous urate crystals, Week 84, 1+ | 8 |
| Amorphous urate crystals, Week 96, 1+ | 3 |
| Bacteria, Week 60, 1+ | 15 |
| Bacteria, Week 72, 1+ | 7 |
| Bacteria, Week 72, 2+ | 3 |
| Bacteria, Week 84, 1+ | 9 |
| Bacteria, Week 84, 2+ | 2 |
| Bacteria, Week 96, 1+ | 9 |
| Bacteria, Week 96, 2+ | 1 |
| Calcium oxalate crystals, Week 60, 1+ | 14 |
| Calcium oxalate crystals, Week 72, 1+ | 12 |
| Calcium oxalate crystals, Week 84, 1+ | 16 |
| Calcium oxalate crystals, Week 96, 1+ | 4 |
| RTEC, Week 60, 0-0.1/Some Field | 19 |
| RTEC, Week 60, 0.2-0.4/Some Field | 7 |
| RTEC, Week 60, 1-2/Every Field | 1 |
| RTEC, Week 72, 0-0.1/Some Field | 14 |
| RTEC, Week 72, 0.2-0.4/Some Field | 5 |
| RTEC, Week 84, 0-0.1/Some Field | 9 |
| RTEC, Week 84, 0.2-0.4/Some Field | 4 |
| RTEC, Week 84, 1-2/Every Field | 2 |
| RTEC, Week 84, 3-5/Every Field | 1 |
| RTEC, Week 96, 0-0.1/Some Field | 15 |
| RTEC, Week 96, 0.2-0.4/Some Field | 2 |
| RTEC, Week 96, 1-2/Every Field | 1 |
| Urine glucose, Week 60, 3+ | 1 |
| Urine glucose, Week 72, 1+ | 1 |
| Urine glucose, Week 72, 2+ | 1 |
| Hyaline casts, Week 60, 0-0.1/Some Field | 4 |
| Hyaline casts, Week 72, 0-0.1/Some Field | 4 |
| Hyaline casts, Week 72, 0.2-0.4/Some Field | 1 |
| Hyaline casts, Week 84, 0-0.1/Some Field | 2 |
| Hyaline casts, Week 84, 1-2/Whole Field | 1 |
| Hyaline casts, Week 84, 3-5/Whole Field | 1 |
| Hyaline casts, Week 96, 0-0.1/Some Field | 2 |
| Hyaline casts, Week 96, 0.2-0.4/Some Field | 1 |
| Hyaline casts, Week 96, 3-5/Whole Field | 3 |
| Mucus threads, Week 60, 1+ | 27 |
| Mucus threads, Week 72, 1+ | 15 |
| Mucus threads, Week 84, 1+ | 18 |
| Mucus threads, Week 96, 1+ | 19 |
| Urine protein, Week 60, 1+ | 1 |
| Urine protein, Week 60, Trace | 11 |
| Urine protein, Week 72, 1+ | 2 |
| Urine protein, Week 72, Trace | 14 |
| Urine protein, Week 84, 1+ | 2 |
| Urine protein, Week 84, Trace | 17 |
| Urine protein, Week 96, 1+ | 3 |
| Urine protein, Week 96, Trace | 11 |
| RBC, Week 60, 0-0.1/Some Field | 35 |
| RBC, Week 60, 0.2-0.4/Some Field | 17 |
| RBC, Week 60, 1-2/Every Field | 12 |
| RBC, Week 60, 3-5/Every Field | 5 |
| RBC, Week 60, 6-10/Every Field | 1 |
| RBC, Week 60, 10-20/Every Field | 2 |
| RBC, Week 60, 30-50/Every Field | 1 |
| RBC, Week 72, 0-0.1/Some Field | 45 |
| RBC, Week 72, 0.2-0.4/Some Field | 11 |
| RBC, Week 72, 1-2/Every Field | 12 |
| RBC, Week 72, 3-5/Every Field | 3 |
| RBC, Week 72, 30-50/Every Field | 2 |
| RBC, Week 84, many/Every Field | 1 |
| RBC, Week 84, 0-0.1/Some Field | 40 |
| RBC, Week 84, 0.2-0.4/Some Field | 9 |
| RBC, Week 84, 1-2/Every Field | 15 |
| RBC, Week 84, 3-5/Every Field | 3 |
| RBC, Week 84, 6-10/Every Field | 2 |
| RBC, Week 84, 20-30/Every Field | 1 |
| RBC, Week 84, 30-50/Every Field | 1 |
| RBC, Week 96, many/Every Field | 1 |
| RBC, Week 96, 0-0.1/Some Field | 44 |
| RBC, Week 96, 0.2-0.4/Some Field | 11 |
| RBC, Week 96, 1-2/Every Field | 11 |
| RBC, Week 96, 3-5/Every Field | 4 |
| RBC, Week 96, 10-20/Every Field | 1 |
| Spermatozoa, Week 84, 1+ | 1 |
| SEC, Week 60, 0-0.1/Some Field | 52 |
| SEC, Week 60, 0.2-0.4/Some Field | 7 |
| SEC, Week 60, 1-2/Every Field | 9 |
| SEC, Week 60, 3-5/Every Field | 2 |
| SEC, Week 60, 10-20/Every Field | 2 |
| SEC, Week 60, 20-30/Every Field | 1 |
| SEC, Week 72, 0-0.1/Some Field | 55 |
| SEC, Week 72, 0.2-0.4/Some Field | 6 |
| SEC, Week 72, 1-2/Every Field | 5 |
| SEC, Week 72, 3-5/Every Field | 1 |
| SEC, Week 72, 6-10/Every Field | 2 |
| SEC, Week 72, 10-20/Every Field | 1 |
| SEC, Week 72, 20-30/Every Field | 3 |
| SEC, Week 84, many/Every Field | 1 |
| SEC, Week 84, 0-0.1/Some Field | 52 |
| SEC, Week 84, 0.2-0.4/Some Field | 8 |
| SEC, Week 84, 1-2/Every Field | 5 |
| SEC, Week 84, 3-5/Every Field | 4 |
| SEC, Week 84, 6-10/Every Field | 2 |
| SEC, Week 96, 0-0.1/Some Field | 56 |
| SEC, Week 96, 0.2-0.4/Some Field | 4 |
| SEC, Week 96, 1-2/Every Field | 8 |
| SEC, Week 96, 3-5/Every Field | 1 |
| SEC, Week 96, 6-10/Every Field | 2 |
| SEC, Week 96, 10-20/Every Field | 1 |
| TEC, Week 60, 0-0.1/Some Field | 3 |
| TEC, Week 60, 0.2-0.4/Some Field | 1 |
| TEC, Week 72, 0-0.1/Some Field | 7 |
| TEC, Week 84, 0-0.1/Some Field | 3 |
| TEC, Week 96, 0-0.1/Some Field | 5 |
| UAC, Week 60, 1+ | 1 |
| UAC, Week 72, 1+ | 1 |
| UAC, Week 96, 1+ | 2 |
| WBC, Week 60, 0-0.1/Some Field | 38 |
| WBC, Week 60, 0.2-0.4/Some Field | 19 |
| WBC, Week 60, 1-2/Every Field | 12 |
| WBC, Week 60, 3-5/Every Field | 2 |
| WBC, Week 60, 6-10/Every Field | 1 |
| WBC, Week 60, 10-20/Every Field | 1 |
| WBC, Week 72, 0-0.1/Some Field | 39 |
| WBC, Week 72, 0.2-0.4/Some Field | 19 |
| WBC, Week 72, 1-2/Every Field | 7 |
| WBC, Week 72, 3-5/Every Field | 2 |
| WBC, Week 72, 6-10/Every Field | 5 |
| WBC, Week 72, 30-50/Every Field | 1 |
| WBC, Week 84, many/Every Field | 2 |
| WBC, Week 84, 0-0.1/Some Field | 47 |
| WBC, Week 84, 0.2-0.4/Some Field | 12 |
| WBC, Week 84, 1-2/Every Field | 6 |
| WBC, Week 84, 10-20/Every Field | 3 |
| WBC, Week 84, 20-30/Every Field | 1 |
| WBC, Week 84, 30-50/Every Field | 1 |
| WBC, Week 96, 0-0.1/Some Field | 41 |
| WBC, Week 96, 0.2-0.4/Some Field | 18 |
| WBC, Week 96, 1-2/Every Field | 8 |
| WBC, Week 96, 6-10/Every Field | 4 |
| WBC, Week 96, 20-30/Every Field | 1 |
Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
| Micrograms per liter | Tenofovir Disoproxil Fumarate |
|---|---|
| Week 4, n=75 | 206.9 ± 593.69 |
| Week 12, n=74 | 254.6 ± 891.36 |
| Week 24, n=74 | 392.7 ± 1544.73 |
| Week 36, n=73 | 261.1 ± 715.81 |
| Week 48, n=73 | 206.8 ± 580.77 |
| Week 60, n=73 | 309.4 ± 651.85 |
| Week 72, n=73 | 235.7 ± 542.52 |
| Week 84, n=72 | 271.3 ± 616.86 |
| Week 96, n=72 | 196.1 ± 478.68 |
Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
| Milligrams per deciliter | Tenofovir Disoproxil Fumarate |
|---|---|
| Urine Creatinine, Week 4, n=75 | -5.353 ± 64.9427 |
| Urine Creatinine, Week 12, n=74 | 2.047 ± 70.1488 |
| Urine Creatinine, Week 24, n=74 | 11.715 ± 78.3996 |
| Urine Creatinine, Week 36, n=73 | 15.849 ± 67.4606 |
| Urine Creatinine, Week 48, n=73 | 4.674 ± 71.2417 |
| Urine Creatinine, Week 60, n=73 | 5.567 ± 58.5998 |
| Urine Creatinine, Week 72, n=73 | -1.378 ± 62.0304 |
| Urine Creatinine, Week 84, n=72 | 19.337 ± 73.2844 |
| Urine Creatinine, Week 96, n=72 | 10.346 ± 69.2155 |
| Urine phosphate, Week 4, n=75 | -3.87 ± 34.392 |
| Urine phosphate, Week 12, n=74 | -2.08 ± 35.796 |
| Urine phosphate, Week 24, n=74 | 2.46 ± 35.994 |
| Urine phosphate, Week 36, n=73 | 0.85 ± 36.016 |
| Urine phosphate, Week 48, n=73 | 0.68 ± 36.561 |
| Urine phosphate, Week 60, n=73 | -0.09 ± 37.888 |
| Urine phosphate, Week 72, n=73 | 0.85 ± 34.012 |
| Urine phosphate, Week 84, n=72 | 5.21 ± 34.599 |
| Urine phosphate, Week 96, n=72 | -0.72 ± 38.732 |
Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Millimeters of mercury | Tenofovir Disoproxil Fumarate |
|---|---|
| SBP, Baseline (Day 1), n=75 | 122.5 ± 14.15 |
| SBP, Week 4, n=75 | 122.9 ± 12.91 |
| SBP, Week 12, n=74 | 124.9 ± 16.28 |
| SBP, Week 24, n=74 | 121.9 ± 12.33 |
| SBP, Week 36, n=73 | 121.5 ± 14.81 |
| SBP, Week 48, n=73 | 122.5 ± 14.76 |
| SBP, Week 60, n=73 | 124.7 ± 14.68 |
| SBP, Week 72, n=73 | 124.2 ± 15.36 |
| SBP, Week 84, n=72 | 122.1 ± 12.86 |
| SBP, Week 96, n=72 | 120.8 ± 16.07 |
| DBP, Baseline (Day 1), n=75 | 76.0 ± 11.76 |
| DBP, Week 4, n=75 | 75.2 ± 11.12 |
| DBP, Week 12, n=74 | 78.1 ± 10.44 |
| DBP, Week 24, n=74 | 75.6 ± 10.05 |
| DBP, Week 36, n=73 | 75.3 ± 10.18 |
| DBP, Week 48, n=73 | 77.8 ± 11.37 |
| DBP, Week 60, n=73 | 78.0 ± 11.07 |
| DBP, Week 72, n=73 | 77.5 ± 10.88 |
| DBP, Week 84, n=72 | 76.3 ± 10.23 |
| DBP, Week 96, n=72 | 76.1 ± 10.59 |
Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| Beats per minute | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 74.7 ± 9.14 |
| Week 4, n=75 | 75.8 ± 10.51 |
| Week 12, n=74 | 76.0 ± 11.05 |
| Week 24, n=74 | 74.8 ± 10.17 |
| Week 36, n=73 | 74.3 ± 9.53 |
| Week 48, n=73 | 75.3 ± 11.32 |
| Week 60, n=73 | 75.8 ± 10.32 |
| Week 72, n=73 | 74.9 ± 11.35 |
| Week 84, n=72 | 75.5 ± 9.96 |
| Week 96, n=72 | 73.1 ± 10.49 |
Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
| degrees Celsius | Tenofovir Disoproxil Fumarate |
|---|---|
| Baseline (Day 1), n=75 | 36.41 ± 0.382 |
| Week 4, n=75 | 36.43 ± 0.385 |
| Week 12, n=74 | 36.40 ± 0.448 |
| Week 24, n=74 | 36.43 ± 0.416 |
| Week 36, n=73 | 36.45 ± 0.360 |
| Week 48, n=73 | 36.41 ± 0.414 |
| Week 60, n=73 | 36.43 ± 0.375 |
| Week 72, n=73 | 36.42 ± 0.357 |
| Week 84, n=72 | 36.46 ± 0.349 |
| Week 96, n=72 | 36.40 ± 0.334 |
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
| Participants | Tenofovir Disoproxil Fumarate |
|---|---|
| Abnormal-not clinically significant | 20 |
| Abnormal-clinically significant | 1 |
Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.
| Grams per centimeter^2 | Tenofovir Disoproxil Fumarate |
|---|---|
| Femur, Week 48, n=4 | -0.0125 ± 0.01654 |
| Femur, Week 96, n=22 | -0.0205 ± 0.02765 |
| Lumbar vertebra, Week 24, n=1 | 0.0100 ± NA |
| Lumbar vertebra, Week 48, n=6 | -0.0100 ± 0.04121 |
| Lumbar vertebra, Week 72, n=1 | -0.0620 ± NA |
| Lumbar vertebra, Week 96, n=72 | -0.0193 ± 0.03539 |
Collected over SAEs and non-SAEs were collected from the start of the treatment up to Week 96.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tenofovir Disoproxil Fumarate | 0/75 (0%) | 2/75 (2.7%) | 36/75 (48%) |
| Event | Tenofovir Disoproxil Fumarate |
|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/75 |
| AppendicitisInfections and infestations | 1/75 |
| Event | Tenofovir Disoproxil Fumarate |
|---|---|
| NasopharyngitisInfections and infestations | 19/75 |
| Beta 2 microglobulin urine increasedInvestigations | 17/75 |
| HeadacheNervous system disorders | 4/75 |
| Dental cariesGastrointestinal disorders | 4/75 |
| Back painMusculoskeletal and connective tissue disorders | 4/75 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/75 |
| Age, Continuous(Years) | Tenofovir Disoproxil Fumarate |
|---|---|
| Mean | 48.4 ± 9.35 |
| Sex: Female, Male(Participants) | Tenofovir Disoproxil Fumarate |
|---|---|
| Female | 20 |
| Male | 55 |
| Race/Ethnicity, Customized(Participants) | Tenofovir Disoproxil Fumarate |
|---|---|
| Asian-East Asian Heritage | 4 |
| Asian-Japanese Heritage | 71 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Oct 2017 to primary completion in Dec 2018, 14 months.
Results were first posted in Jan 2020, 1 year after primary completion.
Of 63 phase 4 interventional studies under Hepatitis B, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 64. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenofovir