National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses (HEPDELTA)

ANRS, Emerging Infectious Diseases

Status: Enrolling

Conditions: Hepatitis B, Chronic; Hepatitis D, Chronic

Treatments: Other: Blood draw for the laboratory assessment

Study type: Observational

Funder types: Other

Identifiers

NCT04166266

ANRS HD EP01-HEPDELTA

Details and patient eligibility

About

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.

Full description

This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:

• Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;
• Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.

Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:

• Samples for the biobank,
• Self-administered questionnaires.

In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 1 patient group

Adults with co-infection with hepatitis B and Delta viruses,

Description:

Blood 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:

Other: Blood draw for the laboratory assessment