Phase 3b Study on Safety and Effectiveness of Undiluted I.V.-Hepabig Injection in Adults After Liver Transplant for Hepatitis B

What this Trial Is About

Researchers are evaluating the safety and effectiveness of undiluted intravenous infusion of I.V.-Hepabig injection in patients who have undergone liver transplantation due to hepatitis B-related end-stage liver disease. The study focuses on people aged 18 to 64 who have a history of liver transplant and have been treated to prevent hepatitis B recurrence. This phase 3b trial aims to compare two methods of administering the I.V.-Hepabig injection to better understand its impact on this patient group. Participants will be randomly assigned to one of two groups one receiving an undiluted infusion of I.V.-Hepabig injection 10,000 International Units over about 30 minutes, and the other receiving a diluted infusion of the same dose mixed with Dextrose 5% in water over about 1 hour. Both treatments are biological therapies given intravenously, and the study compares these two infusion methods for safety and efficacy. During the study, participants will be closely monitored over 20 weeks following the first dose of the investigational product. Researchers will assess adverse events, hepatitis B markers including surface antigen and antibodies, liver virus DNA levels, vital signs, physical exams, and laboratory tests at screening and several time points throughout the study. This monitoring helps evaluate the treatments safety and effects over time, with participant involvement lasting through the 20-week observation period.

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.