Clinical trial Recruiting at 1 site Observational Ages 18 and up

Long-term outcomes of antiviral therapies for chronic hepatitis B

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

Run by Huashan Hospital · NCT04896255 · Data updated 2026-11-12

This study is testing how well two different antiviral treatments for chronic hepatitis B work over five years to see if they help prevent serious liver problems.

More Chronic Hepatitis B trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment33000 (estimated)
SponsorHuashan Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedSeptember 9, 2020
Main results expectedNovember 1, 2026
Study endsDecember 31, 2031
Registry record updatedOctober 6, 2025
Trial IDNCT04896255 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with chronic hepatitis B who are starting or currently receiving antiviral treatment.

Probably not a fit

Patients currently participating in treatment-related clinical trials may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective study recruits patients with chronic hepatitis B who are undergoing antiviral treatment. Participants will be allocated to either a peginterferon alpha-based regimen or nucleos(t)ide therapy based on their doctor's decision. The study aims to compare long-term outcomes, such as the incidence of hepatocellular carcinoma and decompensated cirrhosis, over a follow-up period of five years. Additionally, it will evaluate serological response rates and the predictive value of HBV-related laboratory tests throughout the treatment course.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the most effective antiviral therapies for chronic hepatitis B, potentially improving patient outcomes.

How similar studies have gone: Other studies have shown success in evaluating antiviral therapies for hepatitis B, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Huashan Hospital
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.