Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B — OASIS  

Chronic Hepatitis b Clinical Trial

Official title: Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Prospective, Multicenter, Real-world Study

Status Recruiting

Clinical Trial Summary

This is a multicenter, prospective, real-world study, recruiting patients with chronic hepatitis B under anti-viral treatment. The recruited participants will receive peginterferon alpha based regimen or nucleos(t)ide alone. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. The follow-up time course of this study will be 5 years.

Clinical Trial Description

The patients will be allocated into two cohorts based on the anti-viral treatment decided by their doctors. If they are going to take peginterferon alpha based regimen, they will be allocated in interferon cohort. If they are going to take nucleos(t)ide alone, they will be allocated in nucleos(t)ide cohort. The follow-up plan will be made by their doctors according to their conditions. No extra intervention or examination will be given in this study. The primary outcome is end-stage liver diseases including hepatocellular carcinoma and decompensated cirrhosis, and the rate of hepatocellular carcinoma and decompensated cirrhosis will be measure at 1 year，2 years，3 years, 4 years and 5 years from baseline. Secondary events including HBsAg loss, HBeAg conversion, fibrosis progression and fibrosis, which will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively. Results of laboratory testings will be recorded at each follow-up visit. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etc）of different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. ;

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

• NCT number: NCT04896255
• Study type: Observational [Patient Registry]
• Source: Huashan Hospital
• Contact: Wenhong Zhang, Professor
• Phone: 13801844344
• Email: zhangwenhong@fudan.edu.cn
• Status: Recruiting
• Start date: May 10, 2021
• Completion date: July 25, 2030