Actively Recruiting

Age: 18Years +
All Genders
ID04166266

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

Led by ANRS, Emerging Infectious Diseases · Updated on 2025-02-05

800

Participants Needed

38

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients co-infected with hepatitis B and Delta viruses to better understand their condition and how different management approaches affect the disease. This observational study collects both past and ongoing data, including biological samples, to explore the natural and treated history of hepatitis Delta infection. The study is being conducted by ANRS, Emerging Infectious Diseases, with the goal of improving knowledge about this co-infection. Participants will be monitored following usual medical recommendations based on their treatment status. Those never treated or treated only with peginterferon alpha 2a will have check-ups every six months. Patients treated with specific hepatitis Delta therapies will be followed according to treatment protocols and routine care after treatment ends. The study includes blood sampling for a biobank and additional samples for sub-studies involving certain patient groups. Self-administered questionnaires are also part of the participation requirements. During the study, participants will undergo regular assessments including blood tests, questionnaires on quality of life and substance use, and monitoring of liver function and viral levels. Researchers will track numerous outcomes such as virological responses, treatment adherence, adverse events, liver fibrosis, and progression towards liver complications. The study includes follow-up visits scheduled at specific weeks during and after treatment, continuing until December 2027. This comprehensive monitoring helps researchers gather detailed information on the disease and treatment effects over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years
  • Presenting a chronic HDV infection (positive serology)
  • Provided written informed consent before any intervention and at inclusion
  • Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (exemption request pending)
Not Eligible

You will not qualify if you...

  • Participating in another biomedical research with an exclusion period ongoing at inclusion
  • Vulnerable patient (minor, legally protected adult under judicial protection, guardianship, or supervision, or deprived of liberty)
  • Patients with predictable difficulties of follow-up according to the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Ongoing throughout the study period until December 2027

Participants who have never received specific treatment for hepatitis Delta or are receiving peginterferon alpha 2a alone will be monitored according to current recommendations.

Visits every 6 months

Monitoring

Duration - Up to approximately 3 years of treatment plus follow-up until December 2027

Participants treated or having been treated with specific hepatitis Delta treatment will be monitored during treatment and according to routine follow-up after treatment ends.

Regular visits during treatment and follow-up visits after treatment completion; additional visits depending on compassionate access protocol or routine care

Trial Site Locations

Total: 38 locations

1

CHU of Angers

Angers, France

Actively Recruiting

2

Centre Hospitalier de la région annécienne

Annecy, France

Not Yet Recruiting

3

Avicenne Hospital - Hepatology

Bobigny, France

Actively Recruiting

4

Avicenne Hospital

Bobigny, France

Actively Recruiting

5

Haut Lévêque Hospital

Bordeaux, France

Actively Recruiting

6

Estaing Hospital

Clermont-Ferrand, France

Actively Recruiting

7

Beaujon Hospital

Clichy, France

Actively Recruiting

8

Centre Hospitalier Intercommunal

Créteil, France

Actively Recruiting

9

Henri Mondor Hospital

Créteil, France

Actively Recruiting

10

Bocage Hospital

Dijon, France

Actively Recruiting

11

Michallon Hospital

Grenoble, France

Actively Recruiting

12

Claude Huriez Hospital

Lille, France

Actively Recruiting

13

Dupuytren Hospital

Limoges, France

Actively Recruiting

14

Croix Rousse Hospital

Lyon, France

Actively Recruiting

15

Edouard Herriot Hospital

Lyon, France

Actively Recruiting

16

Hôpital de la Croix Rousse

Lyon, France

Actively Recruiting

17

SAint Joseph Hospital

Marseille, France

Actively Recruiting

18

Saint Eloi Hospital

Montpellier, France

Actively Recruiting

19

Hotel Dieu Hospital

Nantes, France

Actively Recruiting

20

Hôtel-Dieu Hospital

Nantes, France

Actively Recruiting

21

l'Archet 2 Hospital

Nice, France

Actively Recruiting

22

La Source Hospital

Orléans, France

Actively Recruiting

23

Bichat-Claude Bernard Hospital

Paris, France

Actively Recruiting

24

Cochin Hospital

Paris, France

Actively Recruiting

25

Hôpital Tenon

Paris, France

Actively Recruiting

26

La Pitié Salpêtrière Hospital

Paris, France

Actively Recruiting

27

Lariboisière Hospital

Paris, France

Not Yet Recruiting

28

Pitié-Salpêtrière Hospital

Paris, France

Actively Recruiting

29

Saint Antoine Hospital

Paris, France

Actively Recruiting

30

Saint Louis Hospital

Paris, France

Actively Recruiting

31

Saint-Antoine Hospital

Paris, France

Actively Recruiting

32

Pontchaillou Hospital

Rennes, France

Actively Recruiting

33

Charles Nicolle Hospital

Rouen, France

Actively Recruiting

34

Nouvel Hôpital Civil

Strasbourg, France

Actively Recruiting

35

Hôpital Rangueil

Toulouse, France

Actively Recruiting

36

Rangueil Hospital

Toulouse, France

Actively Recruiting

37

Trousseau Hospital

Tours, France

Actively Recruiting

38

Paul Brousse Hospital

Villejuif, France

Actively Recruiting

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Research Team

C

COULIBALY Fatoumata

C

Claire FOUGEROU-LEURENT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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