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)
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Jiaying Wen PM
wenjiaying@hhhbio.com
+86 13552466248
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2030-01-29
Participants
Target number of participants: 160
Treatments
Experimental: Libevitug 20 mg/kg
Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks
Experimental: Libevitug 10 mg/kg
Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks
Active_comparator: Control group/delayed treatment with libevitug 20 mg/kg
Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks
Related Therapeutic Areas
Sponsors
Leads: Huahui Health