Phase III Study Evaluating the Safety and Effectiveness of Libevitug Infusions in People Aged 12 to 70 With Chronic Hepatitis D Infection

What this Trial Is About

Researchers are conducting an international, multicenter, randomized, controlled, open-label Phase III trial to evaluate the efficacy and safety of libevitug in people with chronic Hepatitis Delta Virus HDV infection. The study aims to compare different doses of libevitug and observe outcomes related to viral load and liver health. Participants will be assigned to one of three groups receiving libevitug at 20 mgkg every two weeks via intravenous infusion for 96 weeks, receiving libevitug at 10 mgkg every two weeks via intravenous infusion for 96 weeks, or being observed for 48 weeks followed by receiving libevitug 20 mgkg every two weeks for 48 weeks. This design allows comparison between dosing regimens and delayed treatment. During the study, participants will undergo regular assessments including measurements of HDV RNA levels, liver enzyme normalization, liver stiffness, and liver function scores over a period extending up to 120 weeks. Safety monitoring will include tracking treatment-emergent adverse events. The primary outcome is the proportion of participants achieving specific viral load and liver enzyme targets by Week 48. Participation involves intravenous infusions and scheduled visits for evaluations and laboratory testing.

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