Phase II Study of AHB-137 Injection Combined with Pegylated Interferon or Hepatitis B Vaccine in Adults with HBeAg-Negative Chronic Hepatitis B Treated with Nucleoside Analogues

What this Trial Is About

This trial evaluates the safety and effectiveness of AHB-137 injection combined with other hepatitis B treatments in adults with HBeAg-negative chronic hepatitis B CHB who are already receiving nucleoside analogue therapy. It is a randomized, open-label, multicenter phase II study designed to find out if this combination can help control the virus better and improve patient outcomes. Participants are assigned to one of several groups receiving AHB-137 along with either pegylated interferon alpha-2b, hepatitis B vaccine, or both. The treatment durations vary, with some groups receiving AHB-137 for 16 or 24 weeks alone or in combination with pegylated interferon for up to 24 weeks. All treatments are administered by injection as part of the study protocol. During the study, participants will have regular assessments including measurements of hepatitis B surface antigen and viral DNA levels, liver enzyme tests, and antibody detection. Safety will be closely monitored through adverse event tracking and quality of life questionnaires. The primary outcome is the proportion of participants maintaining very low hepatitis B markers 24 weeks after stopping treatment, with follow-up assessments lasting up to 72 weeks after treatment completion.

A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs