National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
HEPDELTA
1 other identifier
observational
800
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
February 5, 2025
August 1, 2024
7.9 years
September 12, 2019
February 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study the natural or treated history of patients infected with HDV according to different management modalities.
This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.
At the end of the follow-up, december 2027
Secondary Outcomes (32)
Number of patient's reported outcomes measured with specific questionnaire
weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of observance measured with specific questionnaire
weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Alcohol consumption (AUDIT-c), tobacco and cannabis use
weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Socio-economic situation measured with specific questionnaire
weeks 24, 48, end of treatment and 48 weeks after the end of treatment
Quality of life level measured with short-form 12 (SF12) questionnaire
At weeks 24, 48, end of treatment and 48 weeks after the end of treatment
- +27 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included. Patients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.
You may qualify if:
- Age \> 18 years,
- Presenting a chronic HDV infection (positive serology),
- Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
CHU of Angers
Angers, France
Centre Hospitalier de la région annécienne
Annecy, France
Avicenne Hospital - Hepatology
Bobigny, France
Avicenne Hospital
Bobigny, France
Haut Lévêque Hospital
Bordeaux, France
Estaing Hospital
Clermont-Ferrand, France
Beaujon Hospital
Clichy, France
Centre Hospitalier Intercommunal
Créteil, France
Henri Mondor Hospital
Créteil, France
Bocage Hospital
Dijon, France
Michallon Hospital
Grenoble, France
Claude Huriez Hospital
Lille, France
Dupuytren Hospital
Limoges, France
Croix Rousse Hospital
Lyon, France
Edouard Herriot Hospital
Lyon, France
Hôpital de la Croix Rousse
Lyon, France
SAint Joseph Hospital
Marseille, France
Saint Eloi Hospital
Montpellier, France
Hotel Dieu Hospital
Nantes, France
Hôtel-Dieu Hospital
Nantes, France
l'Archet 2 Hospital
Nice, France
La Source Hospital
Orléans, France
Bichat-Claude Bernard Hospital
Paris, France
Cochin Hospital
Paris, France
Hôpital Tenon
Paris, France
La Pitié Salpêtrière Hospital
Paris, France
Lariboisière Hospital
Paris, France
Pitié-Salpêtrière Hospital
Paris, France
Saint Antoine Hospital
Paris, France
Saint Louis Hospital
Paris, France
Saint-Antoine Hospital
Paris, France
Pontchaillou Hospital
Rennes, France
Charles Nicolle Hospital
Rouen, France
Nouvel Hôpital Civil
Strasbourg, France
Hôpital Rangueil
Toulouse, France
Rangueil Hospital
Toulouse, France
Trousseau Hospital
Tours, France
Paul Brousse Hospital
Villejuif, France
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabien ZOULIM
Hôpital de la Croix-Rousse
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 7 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2019
First Posted
November 18, 2019
Study Start
February 19, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
February 5, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share