Actively Recruiting
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
Eligibility Criteria
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)
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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