HEPDELTAObservatory for Hepatitis B and Delta Co-infected Patients
This study aims to observe and understand the natural or treated progression of Hepatitis B and Delta co-infection in patients, considering different management strategies.
Data Collection
Blood-Borne Infections+17
+ Chronic Disease
+ Communicable Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 19, 2020
Actual date on which the first participant was enrolled.This study focuses on individuals who are co-infected with both hepatitis B and Delta viruses. The main goal is to observe and understand the natural progression of these diseases, both in patients who have never received specific treatment for hepatitis Delta and in those who have. The study is important as it aims to provide insights into the different management strategies for this co-infection, potentially improving care and treatment approaches for affected individuals. Participants in this study will be monitored according to standard recommendations, with check-ups scheduled every six months. Those who have received or are receiving specific treatment for hepatitis Delta will be monitored as per their treatment protocol. Being part of this research also involves contributing samples to a biobank and completing self-administered questionnaires. It's worth noting that sub-studies may be conducted within this research, which could involve additional procedures for specific patient groups. The study does not specify a primary endpoint, as it aims to explore multiple objectives related to the course of the disease under various management strategies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.800 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age \> 18 years, * Presenting a chronic HDV infection (positive serology), * Who gave his written informed consent before any intervention and the day of inclusion at the latest, * Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending). Exclusion Criteria: * Patient participating in another biomedical research with an exclusion period ongoing at inclusion, * Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty). * Patients with predictable difficulties of follow-up according to the investigator.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 38 locations
Avicenne Hospital - Hepatology
Bobigny, FranceAvicenne Hospital
Bobigny, FranceHaut Lévêque Hospital
Bordeaux, France