An interventional study of Entecavir and Tenofovir Disoproxil Fumarate in Hepatitis B and Acute-On-Chronic Liver Failure, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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Among 21 studies testing tenofovir alafenamide in Hepatitis B — 10 open to participants now, 12 under way, 1 of them phase 3. tenofovir alafenamide · Hepatitis B.
Among the 21 studies testing tenofovir alafenamide in Hepatitis B, this one is the 7th largest by planned enrollment, is one of 5 that started in 2019, is one of 5 with no phase, reaches primary completion later than 2 of the 11 other live ones, and was the 9th registered.
1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →10 of the 21 studies testing tenofovir alafenamide in Hepatitis B are open now, in 3 countries. Recruiting first, the newest first:
Guangzhou 8th People's Hospital · Sites in China
Ages 20–40 · Women only
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 18–65
Taichung Veterans General Hospital · Sites in Taiwan
Ages 20+
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 20–40 · Women only
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 20–40 · Women only
By country, each count listing its studies:
tenofovir alafenamide: first FDA approval 2015 (GENVOYA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 12 Years to 65 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.
21 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 5 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is close to the median of 145 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 120 across the 21 interventional studies. Of the 4 that completed or were terminated, 2 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 21 have an industry lead sponsor. The 10 most frequent:
Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
17 studies in Hepatitis B by Third Affiliated Hospital, Sun Yat-Sen University: 5 open now, 6 under way, none of them phase 3. Of 2 finished, 0 (0%) have results posted.
Among the 17 studies in Hepatitis B by Third Affiliated Hospital, Sun Yat-Sen University, this one is the 4th largest by planned enrollment of the 13 interventional ones that give a count, is one of 6 that started in 2019, is one of 7 with no phase, and was the 6th registered.
Third Affiliated Hospital, Sun Yat-Sen University’s Hepatitis B studies by the year they started, since 2011.
3 of the studies testing tenofovir alafenamide in Hepatitis B that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06221657Yonsei UniversityClinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment | 2026-12-01 |
| NCT07668934The Third Affiliated Hospital of Guangzhou Medical UniversityTAF in Early/Middle Pregnancy With CHB | 2027-03-30 |
| NCT07253220Sun Yat-sen UniversityTAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma | 2027-09-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies testing tenofovir alafenamide in Hepatitis B, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Third Affiliated Hospital, Sun Yat-Sen University’s 17 in Hepatitis B:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
Drug: Entecavir
50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
Drug: Tenofovir Disoproxil Fumarate
50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Drug: Tenofovir Alafenamide
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Also known as: Baraclude
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Also known as: Viread
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Also known as: Vemlidy
Survival rate in the follow-up
Whether patients will survive after treatment is observed in the follow-up.
Time frame: 144 week
Model for end-stage liver disease (MELD) score is recorded after treatment
The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln\[serum total bilirubin (mg/dl)\]+1.12ln(prothrombin time international normalized ratio)+0.95ln\[serum creatinin(mg/dl)\]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment.
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.
Time frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Started Feb 2019 (actual). Primary completion is estimated for Dec 2024, 70 months after the start.
Of 62 non-industry interventional studies with no phase under Hepatitis B, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 70 months is above that.
Counting every sponsor, half of 68 studies reached it within 29 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Tenofovir alafenamide
Third Affiliated Hospital, Sun Yat-Sen University →