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A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)

Who can join

Ages 12 to 70 · All sexes

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.

About the study

This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.

What is being tested

• Libevitug 20 mg/kg (drug)
• Libevitug 10 mg/kg (drug)
• Delayed treatment with libevitug (other)

Sponsor: Huahui Health · Participants: 160 · Started: Apr 22, 2026

Contact the study team

• Jiaying Wen PM · Phone: +86 13552466248

Official record on ClinicalTrials.gov — NCT07499544

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.