Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
Recruiting · NCT03825458 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospices Civils de Lyon
View the official record on ClinicalTrials.gov →Interventions studied
Blood sampling
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
6 locations listed.
- Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse - Lyon, France
- Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales - Lyon, France
- Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant - Lyon, France
- Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Italy
- Gastroenterology and Hepatology department - • Università degli Studi di Palermo - Palermo, Italy
- Infectious diseases and hepatology unit - Azienda Ospedaliero - Parma, Italy