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

NCT03825458 · tracked via the Priya Life Science France tracker

Sponsor

Hospices Civils de Lyon

Phase

Observational

Started

2019-02-25

Last updated

2026-05-22

Condition(s) studied

Hepatitis B

Investigational drug(s) / intervention(s)

Blood sampling

Blood sampling: Blood sampling at each clinical follow-up visit.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

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 sites (6)

Facility	City	Region	Status
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

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Other trials for the same condition

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure) Active, not recruiting

EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV Enrolling by invitation

Screening for Hepatitis B, Hepatitis C and AIDS Viruses Using Dried Blood Spot Recruiting

Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) Active, not recruiting

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03825458 on ClinicalTrials.gov ↗ ← All trials in France