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

Summary

The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates.

Participants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).

Conditions

• Chronic Hepatitis b

Interventions

DRUG

peginterferon alpha based regimen

peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

DRUG

nucleos(t)ide

peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

Sponsors & Collaborators

• Chinese Foundation for Hepatitis Prevention and Control

  collaborator UNKNOWN

• The Third People's Hospital of Taiyuan

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Yunnan Provincial No.1 Hospital

  collaborator UNKNOWN

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Tianjing No.2 People's Hospital

  collaborator UNKNOWN

• Qingdao No.6 People's Hospital

  collaborator UNKNOWN

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Ningbo Beilun District Traditional Chinese Medicine Hospital

  collaborator OTHER

• Wuxi No.5 People's Hospital

  collaborator UNKNOWN

• Taicang No.1 People's hospital

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Huashan Hospital

  lead OTHER

Principal Investigators

• Wenhong Zhang, MD · Huashan Hospital

• Jiming Zhang, MD · Huashan Hospital

• Feng Sun, MD · Huashan Hospital

• Qiran Zhang, MD · Huashan Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-09

Primary Completion

2026-11-01

Completion

2031-12-31

Countries

• China

Study Locations