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Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

NCT04939441 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-23

No results posted yet for this study

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

Interventions

DRUG

Tenofovir alafenamide

Subjects will be treated for 96 weeks with TAF \[Vemlidy® 25mg QD\] monotherapy

Sponsors & Collaborators

  • Beijing Ditan Hospital

    collaborator OTHER

  • ShuGuang Hospital

    collaborator OTHER

  • Tianjin Third Central Hospital

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • The Sixth Peoples Hospital of Zhengzhou

    collaborator UNKNOWN

  • Tianjin Second People's Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Jidong Jia

    lead OTHER

Principal Investigators

  • Jidong Jia · Beijing Friendship Hospital, Capital Medical Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2024-05-01
Completion
2025-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939441 on ClinicalTrials.gov