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New hope for hepatitis d: libevitug enters final testing phase

NCT ID NCT07499544

Disease control Sponsor: Huahui Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing a new drug called libevitug in 160 people with chronic hepatitis D, a serious liver infection. The goal is to see if libevitug can lower the virus in the blood and improve liver health. Participants receive the drug by IV infusion, and the study compares different doses to find the best approach.

What this could mean

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

Active substance
libevitug
What this could lead to
If it works, this could offer a new treatment option to control chronic hepatitis D, reducing virus levels and improving liver function.
What could go wrong
This is an early Phase 3 trial with only 160 participants. The drug may not work for everyone, and side effects are still being studied.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

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

Started

Apr 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 to 70 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: * Willing to sign written informed consent; * Chronic HDV history with at least 6 months; * HDV RNA ≥500 IU/mL at screening; * ALT \>1ULN and \<10×ULN; * Able to communicate well and comply with protocol. Exclusion Criteria: * Concomitant decompensated cirrhosis; * Previous or current HCC or suspicion for HCC; * Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV; * Participants with active hepatitis C infection, or HIV infection; * Alcohol abuse or drug addiction within 1 year; * Participants have participated in other clinical trial within 1 month; * Pregnant, lactating women.

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection

As listed by the trial registrant

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

Chronic HDV infection Chronic hepatitis D infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site 101

    RECRUITING

    Changchun, Jilin, 130033, China

  • Site 103

    RECRUITING

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

  • Site 104

    RECRUITING

    Kashgar, Xinjiang Uygur Autonomous Region, 844000, China

  • Site 201

    RECRUITING

    Garden Grove, California, 92844, United States

  • Site 301

    RECRUITING

    Karachi, Sindh, 74800, Pakistan

  • Site 302

    RECRUITING

    Karachi, Sindh, 75600, Pakistan

  • Site 303

    RECRUITING

    Rawalpindi, Punjab Province, Pakistan

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