Long-term outcomes of antiviral therapies for chronic hepatitis B
Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study
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 |
|---|---|
| Enrollment | 33000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04896255 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic hepatitis B who are starting or currently receiving antiviral treatment.
Not a fit: Patients currently participating in treatment-related clinical trials may not benefit from this study.
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 performed: Other studies have shown success in evaluating antiviral therapies for hepatitis B, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.