Libevitug 20 mg/kgLibevitug 10 mg/kgDelayed treatment with libevitug
Libevitug 20 mg/kg: Route of administration: intravenous infusion
Libevitug 10 mg/kg: Route of administration: intravenous infusion
Delayed treatment with libevitug: Route of administration: intravenous infusion
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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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 — Week 48 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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