Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure. (CirB-RNA)

The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B
• Intervention / Treatment: Other: Blood sampling

• Study Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

• Study Contact: Name: Fabien ZOULIM, Pr; Phone Number: +33 04 26 10 93 55; Email: fabien.zoulim@chu-lyon.fr
• Study Contact Backup: Name: Massimo LEVERO, Pr; Phone Number: +33 04 72 68 19 79; Email: massimo.levrero@inserm.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
    • Contact: Fabien ZOULIM, Pr; Phone Number: +33 04 26 10 93 55; Email: fabien.zoulim@chu-lyon.fr
  • Lyon, France, 69317
    • Recruiting
    • Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
    • Contact: Matthieu GODINOT, MD, PhD; Phone Number: +33 04 72 07 19 79; Email: matthieu.godinot@chu-lyon.fr
    • Principal Investigator: Matthieu GODINOT, MD, PhD
  • Lyon, France, 69677
    • Recruiting
    • Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
    • Contact: Noémie Laverdure, MD, PhD; Phone Number: +33 4 72 12 94 34; Email: noemie.laverdure@chu-lyon.fr
• Italy
  • Milan, Italy, 20122
    • Terminated
    • Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Palermo, Italy, 90133
    • Terminated
    • Gastroenterology and Hepatology department - • Università degli Studi di Palermo
  • Parma, Italy, 43126
    • Terminated
    • Infectious diseases and hepatology unit - Azienda Ospedaliero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of plot samples collected	The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study). This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.	maximum 46 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): June 25, 2029

Study Registration Dates

• First Submitted: December 31, 2018
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 69HCL18_0436; 2018-A02558-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No