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)

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.

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.