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

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

Interventions2

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