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

Recruitingn/aAges 18 Years - anyAllHuashan Hospital
NCT04896255 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, sym

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📋 Eligibility rules (as published)
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.
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What it tests

  • peginterferon alpha based regimen
  • nucleos(t)ide
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Where

1 site
Huashan Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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