Actively Recruiting
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
Led by Huashan Hospital · Updated on 2025-10-06
33000
Participants Needed
1
Research Sites
590 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
C
Chinese Foundation for Hepatitis Prevention and Control
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or older; those over 70 years must be generally stable in health
- Evidence of HBsAg positivity for more than 6 months or HBV-related liver changes
- Planned or currently receiving potent low-resistance nucleos(t)ide analogues such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or tenofovir amibufenamide, or planned to receive PegIFNα-2b, whether treated or treatment-naïve
- Agree to participate and sign informed consent
You will not qualify if you...
- Diagnosed hepatocellular carcinoma or planned treatment for liver cancer at baseline
- Liver failure at baseline
- Currently participating in other interventional clinical trials
- Any other condition deemed unsuitable by investigators or preventing compliance with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital
Shanghai, China, 200040
Actively Recruiting
Research Team
W
Wenhong Zhang, Professor
CONTACT
F
Feng Sun, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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