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)
Huahui Health
160 participants
Apr 22, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria10
- 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.
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Interventions
Route of administration: intravenous infusion
Route of administration: intravenous infusion
Route of administration: intravenous infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07499544