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New study explores Kidney-Friendly hepatitis b drug for transplant patients

NCT ID NCT07267208

Disease control Sponsor: Jongman Kim 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial will enroll 82 stable liver transplant recipients with chronic hepatitis B to see if switching to entecavir orally disintegrating tablets (ETV-ODT) is safe and helps preserve kidney function. Participants will take the drug daily for 48 weeks, and researchers will monitor changes in kidney function and any signs of hepatitis B returning. The study aims to offer a more convenient treatment option that may be gentler on the kidneys.

What this could mean

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

Active substance
Entecavir orally disintegrating tablets (ETV-ODT)
What this could lead to
If successful, this could show that switching to entecavir ODT is safe and may help protect kidney function in liver transplant patients with hepatitis B.
What could go wrong
This is a small, early-phase study with only 82 participants, so results may not apply to all patients. It focuses on kidney function, not on curing hepatitis B, and there is a risk of HBV recurrence.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 82 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 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

19 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. Patients aged 19 years or older. 2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions: 1. AST and ALT \< 35IU/L 2. HBsAg: Negative 3. HBV DNA: Not detected 3. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year. 4. Patients with a tacrolimus trough level maintained between 3-10 ng/mL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent. Exclusion Criteria: 1. Patients who have undergone transplantation of organs other than the liver or re-transplantation. 2. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation. 3. Patients with concurrent viral infections (HCV, HIV). 4. Patients with eGFR \<30 or those undergoing dialysis 5. Pregnant or breastfeeding women. 6. Patients or their spouses/partners who do not agree to use medically acceptable and appropriate contraception methods\* during the clinical trial period. \* Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide. 7. Patients with a history of hypersensitivity to Entecavir. 8. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B virus Liver transplant

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.