Study of Peginterferon Alpha-2b Combined With Nucleoside Analogues for Treating Chronic HBV Carriers With Family History of Liver Cancer

What This Trial Is About

Researchers are evaluating the clinical cure rate and reduction in liver cancer risk among chronic hepatitis B virus HBV carriers who have a family history of liver cancer. This open-label, multicenter study involves 400 individuals and aims to assess the effectiveness, feasibility, and safety of combining PEGylated interferon alpha-2b Peg-IFNb1-2b with nucleostide analogues NA compared to NA treatment alone. The study focuses on patients with a history of positive hepatitis B surface antigen HBsAg and a family history of liver cancer, including first- and second-degree relatives. Participants choose between two treatment groups Group A receives Peg-IFNb1-2b combined with NA, while Group B receives NA monotherapy. In Group A, NA is taken orally once daily continuously, while Peg-IFNb1-2b 180bcg is given as a weekly subcutaneous injection for 48 to 96 weeks depending on response. If HBsAg does not convert to negative by week 48, Peg-IFNb1-2b treatment may continue up to 96 weeks. Group B participants take NA orally once daily. All patients are followed for up to 240 weeks. Participants will undergo evaluations including measuring the clinical cure rate and liver cancer occurrence over an average of 24 weeks, along with monitoring HBsAg levels, seroconversion rates, HBV DNA levels, vital signs, laboratory tests, and treatment-related adverse events. Safety assessments include tracking severe allergic reactions and clinically relevant changes during treatment. The study duration extends through long-term follow-up to capture outcomes and safety data across both treatment approaches.

Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.