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

Hepatitis B Clinical Trial

— CirB-RNA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03825458
• Other study ID #: 69HCL18_0436
• Secondary ID: 2018-A02558-47
• Status: Recruiting
• Start date: February 25, 2019
• Est. completion date: June 25, 2029

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: Fabien ZOULIM, Pr
• Phone: 04 26 10 93 55
• Email: fabien.zoulim[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: June 25, 2029
• Est. primary completion date: June 25, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
France	Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant	Lyon
France	Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse	Lyon
France	Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales	Lyon
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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