Creating a cohort to study viral RNAs as a new biomarker for hepatitis B cure.
Official title: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Run by Hospices Civils de Lyon · NCT03825458 · Data updated 2026-11-12
This study is trying to see if measuring certain viral RNAs in blood samples can help find a new way to tell if people with hepatitis B are getting closer to a cure.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 6 sites (Lyon and 5 other locations) |
| Status | Recruiting |
| Started | February 25, 2019 |
| Main results expected | June 25, 2029 |
| Study ends | June 25, 2029 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT03825458 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults and children over six years old with acute or chronic hepatitis B or those who have experienced HBsAg loss.
✕Probably not a fit
Patients currently participating in interventional trials for hepatitis B treatments may not benefit from this observational study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project, known as the CirB-RNA cohort, aims to establish a biological collection of samples and associated clinical data from patients with hepatitis B infection. The focus is on characterizing and quantifying circulating viral RNAs, which may serve as a new biomarker for achieving a functional cure of hepatitis B. Blood samples will be collected from eligible patients during their medical appointments to support this research. The study includes both adults and children over six years old who meet specific criteria related to hepatitis B.
Why it matters
Potential benefit: If successful, this study could lead to the identification of a new biomarker that helps in monitoring and achieving a functional cure for hepatitis B.
How similar studies have gone: While the approach of using circulating viral RNAs as biomarkers is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible) * Patients requiring blood sampling for medical care at the time of the medical appointment. * Informed patients who do not refuse to participate. * Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study Exclusion Criteria: * Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study. * Persons deprived of their liberty by a judicial or administrative decision * Adults who are subject to a legal protection measure * Children less than 6 years old (in Lyon)
Where it's running
-
Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
Lyon, France Recruiting -
Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
Lyon, France Recruiting -
Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
Lyon, France Recruiting -
Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Terminated -
Gastroenterology and Hepatology department - • Università degli Studi di Palermo
Palermo, Italy Terminated -
Infectious diseases and hepatology unit - Azienda Ospedaliero
Parma, Italy Terminated
Study contacts
- Study coordinator: Fabien ZOULIM, Pr
- Email: fabien.zoulim@chu-lyon.fr
- Phone: 04 26 10 93 55
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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.