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Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
Sponsor: National Taiwan University Hospital
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
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