Overview

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue

Status:
Recruiting

Trial end date:
2023-12-31

Target enrollment:
0

Participant gender:
All

Summary

We will conduct a phase 4, multicenter, open-label trial at 7 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir [ETV], tenofovir disoproxil fumarate [TDF]) for at least 2 years, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF. The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Collaborators:

Chiayi Christian Hospital
Dalin Tzu Chi General Hospital
E-DA Hospital
National Taiwan University Hospital, Yun-Lin Branch
Taipei City Hospital
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Treatments:

Tenofovir

Criteria

Inclusion Criteria A. Switching therapy cohort

1. Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least
2 years, and fulfil the following NUCs discontinuation criteria (1)HBeAg-positive
patients achieving HBeAg seroclearance, and received at least 1-year consolidation
therapy (2) HBeAg-negative patients achieving undetectable HBV DNA for more than 1
year (on 3 occasions, 6 months apart)

2. After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and
ALT > 2x ULN)

3. The retreatment regimen switches to TAF (within 3 months of clinical relapse)

B. Historical continuing therapy cohort

1. Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least
2 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive
patients achieving HBeAg seroclearance, and received at least 1-year consolidation
therapy (2) HBeAg-negative patients achieving undetectable HBV DNA for more than 1
year(on 3 occasions, 6 months apart)

2. After NUC discontinuation, patients had a clinical relapse (HBV DNA > 2000 IU/mL, and
ALT > 2x ULN)

3. The patients continued the original regimen (ETV, TDF) for retreatment (within 3
months of clinical relapse)

Exclusion Criteria

1. Patients who do not fulfill the discontinuation criteria

2. Patients who have HCV, HDV or HIV co-infection

3. Patients who discontinue lamivudine, adefovir, or telbivudine therapy

4. Patients with liver cirrhosis by ultrasonography and clinical diagnosis