Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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
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