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New hope for hepatitis b patients: switching to TAF after relapse

NCT ID NCT04496882

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 260 chronic hepatitis B patients who stopped their antiviral medication and then had a flare-up. They are switched to a drug called tenofovir alafenamide (TAF) to see if it can control the virus and improve liver health. The goal is to measure how many patients achieve undetectable virus levels and normal liver enzyme tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenofovir alafenamide (TAF), a drug to control hepatitis B virus
What this could lead to
If successful, this could show that switching to TAF is an effective way to manage hepatitis B flare-ups after stopping other antivirals, helping patients achieve viral suppression and liver health.
What could go wrong
This is a phase 4 trial, so the drug is already approved, but it may not work for everyone. The study is open-label and lacks a placebo group, which could bias results. Some patients may still experience side effects or incomplete viral control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria A. Switching therapy cohort 1. Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1)HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA \<20 IU/mL) for more than 1 year 2. After NUC discontinuation, patients had a clinical relapse (HBV DNA \> 2000 IU/mL, and ALT \> 2x ULN) 3. The retreatment regimen switches to TAF (within 3.3 months of clinical relapse) B. Historical continuing therapy cohort 1. Chronic hepatitis B patients receiving oral antiviral therapy (ETV, TDF) for at least 1 years, and fulfil the following NUCs discontinuation criteria (1) HBeAg-positive patients achieved HBeAg loss, and received at least 1-year consolidation therapy (2) HBeAg-negative patients achieved virological remission (HBV DNA \<20 IU/mL) for more than 1 year 2. After NUC discontinuation, patients had a clinical relapse (HBV DNA \> 2000 IU/mL, and ALT \> 2x ULN) 3. The patients continued the original regimen (ETV, TDF) for retreatment (within 3.3 months of clinical relapse) Exclusion Criteria 1. Patients who do not fulfill the discontinuation criteria 2. Patients who have HCV, HDV or HIV co-infection 3. Patients who discontinue lamivudine, adefovir, or telbivudine therapy 4. Patients with liver cirrhosis by ultrasonography and clinical diagnosis

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B Hepatitis B reactivation

Contacts and locations

Locations

  • Buddhist Tzu Chi General Hospital, Da-Lin Branch

    Chiayi City, Taiwan

  • Buddhist Tzu-Chi General Hospital Taipei Branch

    Taipei, Taiwan

  • Chia-Yi Christian Hospital

    Chiayi City, Taiwan

  • E-da hospital

    Kaohsiung City, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National Taiwan University Hospital ,Hsin-Chu Branch

    Hsinchu, Taiwan

  • National Taiwan University Hospital, Yun-Lin branch

    Douliu, Taiwan

  • Taipei City Hospital, Renai Branch

    Taipei, Taiwan

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