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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)

RECRUITINGPhase 3Sponsored by Huahui Health
Actively Recruiting
PhasePhase 3
SponsorHuahui Health
Started2026-04-22
Est. completion2028-09-12
Eligibility
Age12 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07499544

Summary

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.

Eligibility

Age: 12 Years – 70 YearsHealthy volunteers accepted
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.

Conditions2

Chronic Hepatitis D InfectionLiver Disease

Interventions2

Libevitug 10 mg/kgLibevitug 20 mg/kg

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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