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

NCT07499544 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: HH003-301
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hepatitis Delta Virus (HDV); Viral hepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Other Outcomes (2)

• 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

Study Arms (3)

Libevitug 20 mg/kg

EXPERIMENTAL

Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks

Drug: Libevitug 20 mg/kg

Libevitug 10 mg/kg

EXPERIMENTAL

Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks

Drug: Libevitug 10 mg/kg

Control group/delayed treatment with libevitug 20 mg/kg

ACTIVE COMPARATOR

Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks

Other: Delayed treatment with libevitug

Interventions

Libevitug 20 mg/kg DRUG

Route of administration: intravenous infusion

Libevitug 20 mg/kg

Libevitug 10 mg/kg DRUG

Route of administration: intravenous infusion

Libevitug 10 mg/kg

Delayed treatment with libevitug OTHER

Route of administration: intravenous infusion

Control group/delayed treatment with libevitug 20 mg/kg

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign written informed consent;
• Male or female, aged 18-70 years; Adolescent participants with chronic HDV infection: Male or female, age ≥12 years and \<18 years at the time of signing the informed consent form (ICF)/assent;
• Chronic HDV history with at least 6 months; For participants who are also recommended for anti-HBV therapy prior first-line NrtIs treatment (ETV, TDF, TAF) should be at least 12 weeks before the planned start of study treatment, or participant is willing to initiate first-line NrtIs treatment; HBV DNA suppressed;
• HDV RNA ≥500 IU/mL at screening;
• ALT \>1×ULN and \<10×ULN at screening;
• Able to communicate well and comply with protocol.

You may not qualify if:

• Concomitant decompensated cirrhosis;
• Previous or current HCC or suspicion for HCC;
• Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease or other clinically significant chronic liver diseases not caused by HDV/HBV;
• Participants with active hepatitis C infection, or HIV infection;
• History of other malignancies other than HCC;
• Clinically significant ECG abnormalities at screening, which is deemed unsuitable for enrollment per investigator's discretion;
• Alcohol abuse or drug addiction within 1 year;
• Participants who have participated in clinical trials of any drug or medical device within 1 month before randomization;
• Pregnant, lactating women, or women of childbearing potential with a positive pregnancy test;
• Any other clinically significant abnormal lab result, severe acute/chronic medical/psychiatric condition, concomitant serious systemic disease.

Sponsors & Collaborators

• Huahui Health: lead

MeSH Terms

Conditions

Hepatitis D

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Jiaying Wen PM

CONTACT

+86 13552466248; wenjiaying@hhhbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): September 12, 2028
• Study Completion (Estimated): January 29, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04