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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis D Infection
• Intervention / Treatment: Drug: Libevitug 20 mg/kg; Drug: Libevitug 10 mg/kg; Other: Delayed treatment with libevitug

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jiaying Wen PM; Phone Number: +86 13552466248; Email: wenjiaying@hhhbio.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130033
      • Recruiting
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Concomitant decompensated cirrhosis;
• Previous or current HCC or suspicion for HCC;
• Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV;
• Participants with active hepatitis C infection, or HIV infection;
• Alcohol abuse or drug addiction within 1 year;
• Participants have participated in other clinical trial within 1 month;
• Pregnant, lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Libevitug 20 mg/kg; Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks	Drug: Libevitug 20 mg/kg; Route of administration: intravenous infusion
Experimental: Libevitug 10 mg/kg; Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks	Drug: Libevitug 10 mg/kg; Route of administration: intravenous infusion
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	Other: Delayed treatment with libevitug; Route of administration: intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Proportion of participants with HDV RNA below Lower Limit of Quantification (LLOQ) with target not detected (TND) or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization		up to week 96
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline		up to week 96
Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ		up to week 96
Proportion of participants with ALT normalization		up to week 96
Change from baseline in liver stiffness measurement (LSM)		up to week 96
Change from baseline in plasma HDV RNA levels at different time points		up to week 96
Liver related clinical events		up to week 120
Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points		up to week 96
Change from baseline in Child-Pugh score at different time points during the treatment period, extended treatment period and follow-up period. (A higher Child-Pugh score indicates poorer liver function, more severe disease, and a worse prognosis)		up to week 96
Percentage of participants with treatment-emergent adverse events (TEAEs)		up to week 120
Ctrough,ss	Steady-state trough concentration of libevitug	up to week 96

Other Outcome Measures

Outcome Measure	Time Frame
HDV and HBV genotyping	baseline
Change from baseline in quality of life assessed with questionnaire (Hepatitis B quality of life instrument (HBQoL) Version 1.0 and Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) version 4.0 ) at all postbaseline assessments	up to week 120

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): September 12, 2028
• Study Completion (Estimated): January 29, 2030

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Viral hepatitis; Hepatitis Delta Virus (HDV)
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Time-to-Treatment; Treatment Delay
• Other Study ID Numbers: HH003-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No