Creating a cohort to study viral RNAs as a new biomarker for hepatitis B cure.
Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
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 |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 6 sites (Lyon and 5 other locations) |
| Trial ID | NCT03825458 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients currently participating in interventional trials for hepatitis B treatments may not benefit from this observational study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lyon and 5 other locations
- 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 (Recruiting)
- Gastroenterology and Hepatology department - • Università degli Studi di Palermo — Palermo, Italy (Not_yet_recruiting)
- Infectious diseases and hepatology unit - Azienda Ospedaliero — Parma, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Fabien ZOULIM, Pr
- Email: fabien.zoulim@chu-lyon.fr
- Phone: 04 26 10 93 55
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.