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NCT07499544PHASE3Recruiting

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

Huahui Health

Start Date

4/22/2026

Completion Date

1/29/2030

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 Criteria

Age Range: 12 years to 70 years

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.

Interventions

DRUG

Libevitug 20 mg/kg

DRUG

Libevitug 10 mg/kg

OTHER

Delayed treatment with libevitug

Interested in This Trial?

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Conditions

Chronic Hepatitis D Infection

Locations

Site 201

Garden Grove, California 92844

United States

Site 101

Changchun, Jilin 130033

China

Site 104

Kashgar, Xinjiang Uygur Autonomous Region 844000

China

Site 103

Ürümqi, Xinjiang Uygur Autonomous Region 830000

China

Site 303

Rawalpindi, Punjab Province

Pakistan

Site 301

Karachi, Sindh 74800

Pakistan

Site 302

Karachi, Sindh 75600

Pakistan