drugset
drugset / Trial / NCT04496882

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

NCT04496882 ↗

Phase 4 Active not recruiting 260 enrolled National Taiwan University Hospital Chiayi Christian Hospital · collabDalin Tzu Chi General Hospital · collabE-DA Hospital · collabNational Taiwan University Hospital Hsin-Chu Branch · collabNational Taiwan University Hospital, Yun-Lin Branch · collabTaipei City Hospital · collabTaipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\]) for at least 1 year, 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.

Timeline

Start
2020-09-09
Primary completion
2025-01-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject tenofovir alafenamide Small molecule 25 mg Oral

Indications

chronic hepatitis B virus infection