Menu
Recruiting NCT03825458

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

— Observational Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling.
Who it may be relevant to
Registry conditions: Hepatitis B. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Number of plot samples collected [Time frame: maximum 46 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse — Lyon
  • Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales — Lyon
  • Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant — Lyon
Italy · 3 centers
  • Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggio — Milan
  • Gastroenterology and Hepatology department - • Università degli Studi di Palermo — Palermo
  • Infectious diseases and hepatology unit - Azienda Ospedaliero — Parma

Identifiers

NCT: NCT03825458 · 69HCL18_0436 · 2018-A02558-47

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗