Hepatitis BCirB-RNANCT03825458
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 of Hepatitis B, run by Hospices Civils de Lyon at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Blood sampling
- How many people
- 3,500 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 25 Feb 2019to 25 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
France3 sites, 3 recruiting
- Recruiting
Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse
Lyon, 69004
Fabien ZOULIM, Pr, 04 26 10 93 55 ext. +33, fabien.zoulim@chu-lyon.fr
- Recruiting
Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales
Lyon, 69317
Matthieu GODINOT, MD, PhD, 04 72 07 19 79 ext. +33, matthieu.godinot@chu-lyon.fr
Matthieu GODINOT, MD, PhD
- Recruiting
Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant
Lyon, 69677
Noémie Laverdure, MD, PhD, 4 72 12 94 34 ext. +33, noemie.laverdure@chu-lyon.fr
Italy3 sites
- Terminated
Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Terminated
Gastroenterology and Hepatology department - • Università degli Studi di Palermo
Palermo, 90133
- Terminated
Infectious diseases and hepatology unit - Azienda Ospedaliero
Parma, 43126
About this study
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.
- Conditions
- Hepatitis B
- Being tested
- Blood sampling
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling at each clinical follow-up visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: maximum 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start25 Feb 2019
- Primary completion25 Jun 2029 (estimated)
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825458
- Sponsor's protocol ID
- 69HCL18_0436
- Other IDs
- 2018-A02558-47
- Acronym
- CirB-RNA
- Status last verified
- May 2026
- First submitted
- 31 Dec 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
- ClinicalTrials.gov ID
- NCT03825458
- Acronym / sponsor ID
- CirB-RNA / 69HCL18_0436
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 25 Jun 2029 (estimated)
- Study completion
- 25 Jun 2029 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling at each clinical follow-up visit. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Hospices Civils de Lyon at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabien ZOULIM, Pr (04 26 10 93 55 ext. +33, fabien.zoulim@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of plot samples collected (time frame: maximum 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.