A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

Conditions

• Chronic Hepatitis D Infection

Eligibility Criteria

Sex

ALL

Age

12 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Libevitug 20 mg/kg — DRUG
  Route of administration: intravenous infusion
• Libevitug 10 mg/kg — DRUG
  Route of administration: intravenous infusion
• Delayed treatment with libevitug — OTHER
  Route of administration: intravenous infusion

Study Details

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.

Key Dates

First listed

Mar 30, 2026

Start date

Apr 22, 2026

Status verified

Jun 2026

Primary completion

Sep 12, 2028

Completion

Jan 29, 2030

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period [ Time Frame: Week 48 ]

Central Contacts

• Jiaying Wen PM
  +86 13552466248
  [email protected]

Locations (1)