NCT04939441

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 96w Open-label Multicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Jidong Jia · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Tenofovir alafenamide	Subjects will be treated for 96 weeks with TAF \[Vemlidy® 25mg QD\] monotherapy

Timeline

• Start date: 2021-04-20
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2021-06-25
• Last updated: 2023-05-23

Locations

7 sites across 1 country: China