NCT07499544

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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. Eligible participants will be randomized 1:1:1 to one of three groups: libevitug 20 mg/kg group , libevitug 10 mg/kg (N=50) group, or a control/delayed treatment group (N=50). The treatment groups will receive intravenous libevitug every 2 weeks for 96 weeks, while the control group will be observed for the first 48 weeks and then receive libevitug 20 mg/kg Q2W for 48 weeks starting from Week 48.

Conditions

• Chronic Hepatitis D Infection

Interventions

Type	Name	Description
DRUG	Libevitug 20 mg/kg	Route of administration: intravenous infusion
DRUG	Libevitug 10 mg/kg	Route of administration: intravenous infusion
OTHER	Delayed treatment with libevitug	Route of administration: intravenous infusion

Timeline

• Start date: 2026-03-25
• Primary completion: 2028-09-12
• Completion: 2030-01-29
• First posted: 2026-03-30
• Last updated: 2026-04-15

Regulatory

• FDA-regulated drug study