Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)
Key facts
- Where
- Beijing, Nanchang, Shanghai, Suzhou, and Tianjin, ChinaSee the 9 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 69 years old?
Source: NCT04939441, who can take part
Where in China
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaContact: Wen XieTaking people
- Beijing YouAn Hospital,Capital Medical UniversityBeijing, ChinaContact: Huiguo Ding, Doctoral degreeTaking people
- The Ninth Hospital of NanchangNanchang, ChinaContact: Yali Zong, Doctoral degreeTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaContact: Jiming ZhangTaking people
- Ruijin hospitalShanghai, ChinaContact: Qing XieTaking people
- Shuguang hospitalShanghai, ChinaContact: Chenghai LiuTaking people
- The Fifth People's Hospital of SuzhouSuzhou, ChinaContact: Chuanwu Zhu, Doctoral degreeTaking people
- Tianjin Second People's HospitalTianjin, ChinaContact: Ping LiTaking people
- Tianjin Third Central HospitalTianjin, ChinaContact: Tao HanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jidong Jia
- Trial code
- NCT04939441
- Record updated
- 12 November 2026
- Original description
Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). To characterize longitudinal histological changes and assess liver fibrosis regression, the second and third liver biopsies are planned at weeks 96 and 240, respectively. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.Read full original descriptionShow less
Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 240 Weeks Open-label Multicenter Study
Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). To characterize longitudinal histological changes and assess liver fibrosis regression, the second and third liver biopsies are planned at weeks 96 and 240, respectively. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.
Inclusion: 18-69 years old (inclusive); BMI (18-30 kg/m2); Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months; or chronic hepatitis B proven by live biopsy; Not received nucleoside (acid) analogue and/or interferon therapy (treatment-naive); Liver biopsy performed within 6 months before treatment and had readable biopsy slides or agrees to have a biopsy performed prior to baseline; METAVIR fibrosis stage ≥ F2; For patients without cirrhosis (F2/3), HBV DNA levels >2000 IU/mL before treatment; For patients with cirrhosis (F4), HBV DNA >20 IU/mL before treatment; ALT≤10 ULN before treatment; Creatinine clearance ≥ 50 mL/min; Agreement not to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study; Willing and able to provide written informed consent.
Exclusion: Patients with organ or bone marrow transplantation; Patients currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion; Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or liver transplantation; Patients co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV), or alcoholic liver diseases, autoimmune liver disease, genetic liver disease, drug-induced liver injury, non-alcoholic fatty liver disease or other chronic liver diseases; Patients with other uncured malignant tumors; Patients who are allergic to any component of TAF; Patients with active alcohol or drug abuse or history of alcohol or drug abuse (hinder compliance with treatment, or participation in the study or interpretation of results considered by the Investigator); Patients with significant renal, cardiovascular, pulmonary, or neurological disease; Patients with Child-Turcotte-Pugh（CTP）score ≥ 7; Patients with evidence of hepatocellular carcinoma (HCC) by imaging with or without AFP; Patients who recently or newly started bisphosphate (within 1 month); Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study; Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study; Not suitable for this study identified by researchers.