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
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