ClinicalTrials.gg
RecruitingNCT03825458CirB-RNAUpdated May 22, 2026

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

An observational study in Hepatitis B, sponsored by Hospices Civils de Lyon. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,500
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Hepatitis B

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In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's planned enrollment of 3,500 is above the median of 365 across 251 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or and/or 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

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)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherBlood sampling

    Blood sampling at each clinical follow-up visit.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: maximum 46 months

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Study locations

3 of 6 sites recruiting
  • Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
    Lyon, 69004, France
    Recruiting
  • Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
    Lyon, 69317, France
    Recruiting
  • Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
    Lyon, 69677, France
    Recruiting
  • Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
    Terminated

    Not enrolling at this site.

  • Gastroenterology and Hepatology department - • Università degli Studi di Palermo
    Palermo, 90133, Italy
    Terminated

    Not enrolling at this site.

  • Infectious diseases and hepatology unit - Azienda Ospedaliero
    Parma, 43126, Italy
    Terminated

    Not enrolling at this site.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03825458
Responsible party
Sponsor
First posted
Jan 31, 2019
Start date
Feb 25, 2019
Primary completion
Jun 25, 2029 (estimated)
Completion
Jun 25, 2029 (estimated)
Last update
May 22, 2026

Study contacts

Fabien ZOULIM, Pr
Contact
fabien.zoulim@chu-lyon.fr
04 26 10 93 55 ext. +33
Massimo LEVERO, Pr
Contact
massimo.levrero@inserm.fr
04 72 68 19 79 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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