Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT04166266
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2019-09-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEPDELTA
Brief 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: