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

Last updated: February 3, 2025
Sponsor: ANRS, Emerging Infectious Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

Blood draw for the laboratory assessment

Clinical Study ID

NCT04166266
ANRS HD EP01-HEPDELTA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years,

  • Presenting a chronic HDV infection (positive serology),

  • Who gave his written informed consent before any intervention and the day ofinclusion at the latest,

  • Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request forexemption pending).

Exclusion

Exclusion Criteria:

  • Patient participating in another biomedical research with an exclusion periodongoing 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.

Study Design

Total Participants: 800
Treatment Group(s): 1
Primary Treatment: Blood draw for the laboratory assessment
Phase:
Study Start date:
February 19, 2020
Estimated Completion Date:
June 30, 2028

Study 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

Connect with a study center

  • CHU of Angers

    Angers,
    France

    Active - Recruiting

  • Centre Hospitalier de la région annécienne

    Annecy,
    France

    Site Not Available

  • Avicenne Hospital

    Bobigny,
    France

    Active - Recruiting

  • Avicenne Hospital - Hepatology

    Bobigny,
    France

    Active - Recruiting

  • Haut Lévêque Hospital

    Bordeaux,
    France

    Active - Recruiting

  • Estaing Hospital

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Beaujon Hospital

    Clichy,
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal

    Créteil,
    France

    Active - Recruiting

  • Henri Mondor Hospital

    Créteil,
    France

    Active - Recruiting

  • Bocage Hospital

    Dijon,
    France

    Active - Recruiting

  • Michallon Hospital

    Grenoble,
    France

    Active - Recruiting

  • Claude Huriez Hospital

    Lille,
    France

    Active - Recruiting

  • Dupuytren Hospital

    Limoges,
    France

    Active - Recruiting

  • Croix Rousse Hospital

    Lyon,
    France

    Active - Recruiting

  • Edouard Herriot Hospital

    Lyon,
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse

    Lyon,
    France

    Active - Recruiting

  • ZOULIM

    Lyon,
    France

    Active - Recruiting

  • SAint Joseph Hospital

    Marseille,
    France

    Active - Recruiting

  • Saint Eloi Hospital

    Montpellier,
    France

    Active - Recruiting

  • Hotel Dieu Hospital

    Nantes,
    France

    Active - Recruiting

  • Hôtel-Dieu Hospital

    Nantes,
    France

    Active - Recruiting

  • l'Archet 2 Hospital

    Nice,
    France

    Active - Recruiting

  • La Source Hospital

    Orléans,
    France

    Active - Recruiting

  • Bichat-Claude Bernard Hospital

    Paris,
    France

    Active - Recruiting

  • Cochin Hospital

    Paris,
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris,
    France

    Active - Recruiting

  • La Pitié Salpêtrière Hospital

    Paris,
    France

    Active - Recruiting

  • Lariboisière Hospital

    Paris,
    France

    Site Not Available

  • Pitié-Salpêtrière Hospital

    Paris,
    France

    Active - Recruiting

  • Saint Antoine Hospital

    Paris,
    France

    Active - Recruiting

  • Saint Louis Hospital

    Paris,
    France

    Active - Recruiting

  • Saint-Antoine Hospital

    Paris,
    France

    Active - Recruiting

  • Pontchaillou Hospital

    Rennes,
    France

    Active - Recruiting

  • Charles Nicolle Hospital

    Rouen,
    France

    Active - Recruiting

  • Nouvel Hôpital Civil

    Strasbourg,
    France

    Active - Recruiting

  • Hôpital Rangueil

    Toulouse,
    France

    Active - Recruiting

  • Rangueil Hospital

    Toulouse,
    France

    Active - Recruiting

  • Trousseau Hospital

    Tours,
    France

    Active - Recruiting

  • Paul Brousse Hospital

    Villejuif,
    France

    Active - Recruiting

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