NCT03825458

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Feb 2019Jun 2029

First Submitted

Initial submission to the registry

December 31, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

10.3 years

First QC Date

December 31, 2018

Last Update Submit

May 20, 2026

Conditions

Hepatitis B

Outcome Measures

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.

    maximum 46 months

Interventions

Blood samplingOTHER

Blood sampling at each clinical follow-up visit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

Gastroenterology and Hepatology department - • Università degli Studi di Palermo

Palermo, 90133, Italy

TERMINATED

Infectious diseases and hepatology unit - Azienda Ospedaliero

Parma, 43126, Italy

TERMINATED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma EDTA and serum

MeSH Terms

Conditions

Hepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Fabien ZOULIM, Pr

CONTACT

04 26 10 93 55fabien.zoulim@chu-lyon.fr

Massimo LEVERO, Pr

CONTACT

04 72 68 19 79massimo.levrero@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2018

First Posted

January 31, 2019

Study Start

February 25, 2019

Primary Completion (Estimated)

June 25, 2029

Study Completion (Estimated)

June 25, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)IT(3)