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

NCT07499544 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-22
Primary Completion
2028-09-12
Completion
2030-01-29
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499544 on ClinicalTrials.gov