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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-19

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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

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Hepatitis D, Chronic Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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

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.

Blood draw for the laboratory assessment

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No