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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 33000 (estimated) |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | September 9, 2020 |
| Main results expected | November 1, 2026 |
| Study ends | December 31, 2031 |
| Registry record updated | October 6, 2025 |
| Trial ID | NCT04896255 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
- Principal investigator: Wenhong Zhang, MD — Huashan Hospital
- Study coordinator: Wenhong Zhang, Professor
- Email: zhangwenhong@fudan.edu.cn
- Phone: 13801844344
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Impact of functional cure on patient-reported outcomes in chronic hepatitis B
This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.
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This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.
-
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AHB-137 injection in people with chronic hepatitis B
This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.