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New hope for transplant patients with hepatitis b: safer drug switch under study

NCT ID NCT05410496

Disease control Sponsor: Taichung Veterans General 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at switching kidney or liver transplant patients with chronic hepatitis B to a drug called tenofovir alafenamide (TAF). The goal is to see if TAF is safer for the kidneys, controls the virus well, and is easier for patients to stick with. The study involves 52 adults who have already had a transplant and are on other hepatitis B medications.

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)
What this could lead to
If successful, this could offer a safer and more effective way to control hepatitis B in transplant patients, potentially improving kidney function and medication adherence.
What could go wrong
This is a small, single-center study with only 52 participants, so results may not apply to everyone. It's also a switch therapy, not a cure, and long-term risks remain unknown.

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

52 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Jul 2027

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 years and older

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: 1. At least 20 years of age 2. Chronic HBV infection under NA therapy other than TAF 3. Underwent kidney and/ or liver transplantation 4. Without clinical or pathologic evidence of moderate or severe rejection 5. Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs. Exclusion Criteria: 1. End stage renal disease (eGFR \< 15 mL/min/1.73m2) 2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) 3. Any active malignancies 4. Pregnant or breast-feeding women 5. Known allergy to tenofovir-contained regimens

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis hepatitis B virus infection Patient Compliance

As listed by the trial registrant

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

Chronic hepatitis B Safety issues Transplant recipient

Contacts and locations

Locations

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Taichung Veterans General Hospital

    Taichung, Taiwan, 40705, Taiwan

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