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NCT Number: NCT03825458

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

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.

Recruiting

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling

Other

Blood sampling at each clinical follow-up visit.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabien ZOULIM, Pr

CONTACT

[email protected]

04 26 10 93 55 ext. +33

Massimo LEVERO, Pr

CONTACT

[email protected]

04 72 68 19 79 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CirB-RNA

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Jan 31, 2019
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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