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)

Huahui Health

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 range: 12–70 years
Sex: All
Healthy volunteers: No

Detailed criteria

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…

Interventions

Drug
Libevitug 20 mg/kg
Route of administration: intravenous infusion
Drug

Summary

Eligibility

Interventions

Locations (7)