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

NCT ID: NCT03825458

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-25

Study Completion Date

2029-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sampling

Blood sampling at each clinical follow-up visit.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse

Lyon, , France

Site Status RECRUITING

Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales

Lyon, , France

Site Status RECRUITING

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

Lyon, , France

Site Status RECRUITING

Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Gastroenterology and Hepatology department - • Università degli Studi di Palermo

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Infectious diseases and hepatology unit - Azienda Ospedaliero

Parma, , Italy

Site Status NOT_YET_RECRUITING

Countries

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France Italy

Central Contacts

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Fabien ZOULIM, Pr

Role: CONTACT

04 26 10 93 55 ext. +33

Massimo LEVERO, Pr

Role: CONTACT

04 72 68 19 79 ext. +33

Facility Contacts

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Fabien ZOULIM, Pr

Role: primary

04 26 10 93 55 ext. +33

Patrick MIAILHES, MD, PhD

Role: primary

04 26 73 26 58 ext. +33

Noémie Laverdure, MD, PhD

Role: primary

4 72 12 94 34 ext. +33

Pietro LAMPERTICO, Pr

Role: primary

0255035432 ext. +39

Antonio CRAXI, Pr

Role: primary

Carlo FERRARI, Pr

Role: primary

0521702762 ext. +39

Other Identifiers

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2018-A02558-47

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0436

Identifier Type: -

Identifier Source: org_study_id

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