Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Hepatitis B
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04896255
Collaborators
  • Yunnan Provincial No.1 Hospital
  • Chinese Foundation for Hepatitis Prevention and Control
  • Taiyuan No.3 Hospital
  • First Affiliated Hospital of Chongqing Medical University
  • Qingdao No.6 People's Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Beijing YouAn Hospital
  • Wuxi No.5 People's Hospital
  • Henan Provincial People's Hospital
  • Third Affiliated Hospital, Sun Yat-Sen University
  • The First Affiliated Hospital of Anhui Medical University
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • Taicang No.1 People's hospital
  • The First Affiliated Hospital of Xiamen University
  • Beijing Ditan Hospital
  • Tianjing No.2 People's Hospital
  • Ningbo Beilun District Traditional Chinese Medicine Hospital
Investigators
Principal Investigator: Wenhong Zhang, MD Huashan Hospital Principal Investigator: Jiming Zhang, MD Huashan Hospital Study Chair: Feng Sun, MD Huashan Hospital Study Director: Qiran Zhang, MD Huashan Hospital