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.
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;
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;
Parallel
Libevitug 20 mg/kg
DrugRoute of administration: intravenous infusion
Libevitug 10 mg/kg
DrugRoute of administration: intravenous infusion
Delayed treatment with libevitug
Other interventionRoute of administration: intravenous infusion
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
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline
Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ
Proportion of participants with ALT normalization
HDV and HBV genotyping
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
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