UnknownPhase 4

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

China100 participantsStarted 2021-04-20

Plain-language summary

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). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. 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.

Who can participate

Age range18 Years – 69 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Patients with Child-Turcotte-Pugh（CTP）score ≥ 7; * 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 evidence of hepato…

What they're measuring

Proportion of patients with fibrosis regression

Timeframe: Week 96

HBV DNA undetectable rate

Timeframe: Week 96

Trial details

NCT IDNCT04939441

SponsorJidong Jia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01