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 all (7) locations...
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
United States
California
Site 201
RECRUITING
Garden Grove
Other Locations
China
Site 101
RECRUITING
Changchun
Site 104
RECRUITING
Kashgar
Site 103
RECRUITING
Ürümqi
Pakistan
Site 301
RECRUITING
Karachi
Site 302
RECRUITING
Karachi
Site 303
RECRUITING
Rawalpindi
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