Clinical trial Recruiting at 3 sites Observational Ages 18 and up

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.

More Hepatitis B trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment3500 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Locations6 sites (Lyon and 5 other locations)
StatusRecruiting
StartedFebruary 25, 2019
Main results expectedJune 25, 2029
Study endsJune 25, 2029
Registry record updatedMay 22, 2026
Trial IDNCT03825458 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

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.