NCT04166266

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Hepatitis D, Chronic
• Hepatitis B, Chronic

Interventions

Type	Name	Description
OTHER	Blood draw for the laboratory assessment	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.

Timeline

• Start date: 2020-02-19
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2019-11-18
• Last updated: 2025-02-05

Locations

38 sites across 1 country: France