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RECRUITING
NCT04896255

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

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

33000

Start Date

2020-09-09

Completion Date

2031-12-31

Last Updated

2025-10-06

Healthy Volunteers

No

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

Locations (1)

Huashan Hospital

Shanghai, China