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

NCT04896255 · tracked via the Priya Life Science China tracker

Sponsor

Huashan Hospital

Phase

Observational

Started

2020-09-09

Last updated

2025-10-06

Condition(s) studied

Chronic Hepatitis b

Investigational drug(s) / intervention(s)

peginterferon alpha based regimennucleos(t)ide

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

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

rate of hepatocellular carcinoma at 5 year from baseline — 5 year from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline

Trial sites (1)

Facility	City	Region	Status
Huashan Hospital	Shanghai	China	Recruiting

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Other trials for the same condition

The Effectiveness and Safety of TMF in the Treatment of Chronic Hepatitis B Patients With Normal ALT. Active, not recruiting

A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function. Recruiting

Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection Recruiting

A Study to Evaluate the Antiviral Activity and Immune Response of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB) Active, not recruiting

A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04896255 on ClinicalTrials.gov ↗ ← All trials in China