National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases
About this trial
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included. Patients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Blood draw for the laboratory assessment
Other interventionBlood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Adults with co-infection with hepatitis B and Delta viruses,1 intervention
Trial outcomes
Primary outcomes
1
To study the natural or treated history of patients infected with HDV according to different management modalities.
This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.
Time frame
At the end of the follow-up, december 2027Secondary outcomes
1
Number of patient's reported outcomes measured with specific questionnaire
Time frame
weeks 24, 48, end of treatment and 48 weeks after the end of treatment2
Quality of observance measured with specific questionnaire
Time frame
weeks 24, 48, end of treatment and 48 weeks after the end of treatment3
Alcohol consumption (AUDIT-c), tobacco and cannabis use
Time frame
weeks 24, 48, end of treatment and 48 weeks after the end of treatment4
Socio-economic situation measured with specific questionnaire
Time frame
weeks 24, 48, end of treatment and 48 weeks after the end of treatmentSponsors and contacts
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Source ClinicalTrials.gov