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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuashan Hospital

About this trial

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).

Eligibility criteria

Qualifiers

Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.

There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.

Planned or currently receiving potent low-resistance NAs [entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)], or planned to receive PegIFNα-2b, either treated or treatment-naïve.

Agree to participate in the study and sign the patient informed consent form.

Disqualifiers

Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline

Concurrently participating in other interventional clinical trials.

Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.

Trial design

Treatments tested in this trial

  • peginterferon alpha based regimen
  • nucleos(t)ide

Treatment groups

33,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Huashan Hospital

Lead sponsor

Chinese Foundation for Hepatitis Prevention and Control

Collaborator

The Third People's Hospital of Taiyuan

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Beijing YouAn Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

Yunnan Provincial No.1 Hospital

Collaborator

Third Affiliated Hospital, Sun Yat-Sen University

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

Beijing Ditan Hospital

Collaborator

Tianjing No.2 People's Hospital

Collaborator

Qingdao No.6 People's Hospital

Collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborator

Ningbo Beilun District Traditional Chinese Medicine Hospital

Collaborator

Wuxi No.5 People's Hospital

Collaborator

Taicang No.1 People's hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator