Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04496882
PHASE4

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

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Official title: The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy

Key Details

Gender

All

Age Range

20 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2020-09-09

Completion Date

2026-12-31

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

Vemlidy

25mg Tenofovir Alafenamide

Locations (8)

Buddhist Tzu Chi General Hospital, Da-Lin Branch

Chiayi City, Taiwan

Chia-Yi Christian Hospital

Chiayi City, Taiwan

National Taiwan University Hospital, Yun-Lin branch

Douliu, Taiwan

National Taiwan University Hospital ,Hsin-Chu Branch

Hsinchu, Taiwan

E-da hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Buddhist Tzu-Chi General Hospital Taipei Branch

Taipei, Taiwan

Taipei City Hospital, Renai Branch

Taipei, Taiwan