MedTrace Logo

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

NCT04496882 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vemlidy

25mg Tenofovir Alafenamide

Sponsors & Collaborators

  • National Taiwan University Hospital, Yun-Lin Branch

    collaborator OTHER

  • Taipei City Hospital

    collaborator OTHER_GOV

  • Chiayi Christian Hospital

    collaborator OTHER

  • Dalin Tzu Chi General Hospital

    collaborator OTHER

  • E-DA Hospital

    collaborator OTHER

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    collaborator OTHER

  • National Taiwan University Hospital Hsin-Chu Branch

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Tung-Hung Su, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2025-01-01
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496882 on ClinicalTrials.gov