Antiviral Therapy for Patients With Chronic Hepatitis B Infection
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The study aims to demonstrate that antiviral therapy for patients with immune tolerance of
CHB. On the basis of the original antiviral therapy of entecavir, further clarify the safety
and effectiveness of entecavir combined with tenofovir amibufenamide.The investigators plan
to enroll about 328 hepatitis B patients,. who are in the stage of immune tolerance. These
participants will be devided into two groups randomly .Group A will receive the treatment of
entecavir. Group B will be treated with entecavir and tenofovir amibufenamide. The
participants in both groups will be followed up for 96 weeks.
The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The
secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the
two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the
two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4)
Comparing adverse side effects between the two groups.