Combination Treatment of NAs and Peg IFN α-2b for Hepatitis B Related, Compensatory Cirrhosis Patients
Status:
Recruiting
Trial end date:
2024-05-30
Target enrollment:
Participant gender:
Summary
The study aims to demonstrate that whether treatment of nucleoside （acid）analogues (NAs) plus
pegylated interferon (Peg IFN) α-2b for those NAs treated, low level of HBsAg, hepatitis B
related compensatory cirrhosis patients will result in higher HBsAg clearance rate and reduce
the risk of liver cancer. The investigators plan to enroll about 84 hepatitis B related
compensatory cirrhosis patients, who have received NAs treatment more than 1 year with the
level of HBsAg <1000IU/ml. These participants will be devided into 2 groups. Group A will
receive the treatment of NAs plus Peg IFNα-2b. Group B will be treated with NAs as before
enrollment. The participants in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the clearance rate of HBsAg between two groups. The
secondary endpoint includes: (1) comparing the incidence of liver cancer during the 96 weeks
follow-up, (2) comparing adverse side effects between the 2 groups. (3) comparing the
virological and biochemical responses between the 2 groups.