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

Recruiting

• Conditions: Hepatitis B

• Registration Number: NCT03825458
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-31
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Study Start: 2019-02-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2029-06-25
• Study Completion: 2029-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of plot samples collected	maximum 46 months	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.

Trial Locations

Locations (6)

Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Gastroenterology and Hepatology department - • Università degli Studi di Palermo; 🇮🇹 Palermo, Italy

Infectious diseases and hepatology unit - Azienda Ospedaliero; 🇮🇹 Parma, Italy

Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France

Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales; 🇫🇷 Lyon, France

Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant; 🇫🇷 Lyon, France