A Phase 4 interventional study of sofosbuvir/ledipasvir in Chronic Hepatitis C, sponsored by Partners in Health. Completed at 1 site in Rwanda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Partners in Health · Phase 4, Interventional, and Treatment
Among 50 studies testing sofosbuvir in Hepatitis C, Chronic — none open to participants now, 1 under way, none of them phase 3. Sofosbuvir · Hepatitis C, Chronic.
Among the 50 studies testing sofosbuvir in Hepatitis C, Chronic, this one is the 9th largest by enrollment, is one of 5 that started in 2016, is one of 13 in phase 4, and was the 35th registered.
950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.
This study's enrollment of 300 is above the median of 90 across 696 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →None of the 50 studies testing sofosbuvir in Hepatitis C, Chronic is open now.
Sofosbuvir: first FDA approval 2013 (SOVALDI), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 5 Hepatitis C, Chronic studies recruiting now, 2 (40%) set no upper age limit and 2 (40%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 5 started in 2016.
Median enrollment 65 across the 50 interventional studies. Of the 40 that completed or were terminated, 22 (55%) have results posted.
25 of 50 have an industry lead sponsor. The 10 most frequent:
Partners in Health is the lead sponsor of 5 studies on the registry; none are open to participants now.
Partners in Health has 2 studies filed under Hepatitis C, Chronic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 50 studies testing sofosbuvir in Hepatitis C, Chronic, from their registry updates:
The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.
This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.
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.
Exclusion Criteria:
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.
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.
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).
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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 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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
sofosbuvir/ledipasvir once daily for 12 weeks
Drug: sofosbuvir/ledipasvir
Drug pages: Sofosbuvir · Ledipasvir
Also known as: Harvoni
Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment
To determine the hepatitis C virus (HCV) antiviral efficacy of sofosbuvir/ledipasvir (SOF/LDV) fixed-dose combination (FDC) as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda.
Time frame: After study completion (24 weeks)
Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment, with limited lab monitoring
To determine the HCV antiviral efficacy of SOF/LDV FDC, as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12), with limited lab monitoring in Rwanda.
Time frame: After study completion (24 weeks)
Proportion of participants with a new grade 3 or 4 adverse event or premature study drug discontinuation due to an adverse event.
To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda
Time frame: After study completion (24 weeks)
A set of minimum required monitoring tests
A set of minimum required monitoring tests
Time frame: After study completion (24 weeks)
Distribution of HCV genotypes subtypes among participants
Distribution of HCV genotypes subtypes among participants
Time frame: After study completion (24 weeks)
SVR12, stratified by genotypic subtype
SVR12, stratified by genotypic subtype
Time frame: After study completion (24 weeks)
Basic demographic and clinical characteristics of patients referred for HCV treatment
Basic demographic and clinical characteristics of patients referred for HCV treatment
Time frame: After study completion (24 weeks)
Adherence to SOF/LDV measured by pill count
Adherence to SOF/LDV measured by pill count
Time frame: After 12 weeks medication therapy
Proportion of participants with virologic failure
Proportion of participants with virologic failure
Time frame: After study completion (24 weeks)
Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment
Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment
Time frame: After study completion (24 weeks)
Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment
Proportion of HIV co-infected participants that maintain HIV-1 RNA\< 200 copies/mL while on HCV treatment
Time frame: After 12 weeks of medication therapy
Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey
To determine the effect of SOF/LDV and SVR12 on quality of life in Rwanda
Time frame: After study completion (24 weeks)
Plan to share: Yes — The study protocol, study data, data dictionary, data collection instruments, and informed consent forms are available upon request from the corresponding author. De-identifiable individual participant data will be made available 9 months after the publication date and ending 36 months after the publication date. Forms and data can be accessed by written request to the corresponding author and the study sponsor, Partners In Health. The data will be made available following evaluation and approval of proposed use by the study sponsor and signed data access agreement with the study sponsor.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: De-identifiable individual participant data will be made available 9 months after the publication date and ending 36 months after the publication date.
Access criteria: Forms and data can be accessed by written request to the corresponding author and the study sponsor, Partners In Health. The data will be made available following evaluation and approval of proposed use by the study sponsor and signed data access agreement with the study sponsor.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sofosbuvir · Ledipasvir
Partners in Health