NCT04896255Recruiting
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 33000 (estimated)
- First submitted
- 14 May 2021
- Start date
- 9 Sept 2020
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Huashan Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT04896255
What you commit to
- Study type: Observational
- Planned participants: 33000
- From 9 Sept 2020 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline
- Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.
Other
- Concurrently participating in other interventional clinical trials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.