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

November 15, 2023 updated by: Hospices Civils de Lyon
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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
        • Contact:
      • Lyon, France, 69317
        • Recruiting
        • Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
        • Contact:
        • Principal Investigator:
          • Patrick MIAILHES, MD, PhD
      • Lyon, France, 69677
        • Recruiting
        • Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
        • Contact:
  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
      • Palermo, Italy, 90133
        • Not yet recruiting
        • Gastroenterology and Hepatology department - • Università degli Studi di Palermo
        • Contact:
      • Parma, Italy, 43126
        • Not yet recruiting
        • Infectious diseases and hepatology unit - Azienda Ospedaliero
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of plot samples collected
Time Frame: 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.
maximum 46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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