Observational study of patients co-infected with Hepatitis B and Delta viruses
Official title: National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Run by ANRS, Emerging Infectious Diseases · NCT04166266 · Data updated 2026-11-12
This study looks at patients who have both Hepatitis B and Delta viruses to see how their treatment affects their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 38 sites (Angers and 37 other locations) |
| Status | Recruiting |
| Started | February 19, 2020 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT04166266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with chronic hepatitis D infection who can provide informed consent.
✕Probably not a fit
Patients currently participating in other biomedical research or those with predictable follow-up difficulties may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study collects both prospective and retrospective data from patients co-infected with hepatitis B and Delta viruses. Participants will be monitored based on their treatment status, with regular follow-ups every six months for untreated patients and according to specific protocols for those receiving treatment. The study also involves biological sample collection for a biobank and self-administered questionnaires to gather additional data. Sub-studies may be conducted on specific patient groups, potentially involving further interventions.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety and efficacy of treatments for patients co-infected with hepatitis B and Delta viruses.
How similar studies have gone: While there have been studies on hepatitis infections, this specific observational approach for co-infected patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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CHU of Angers
Angers, France Recruiting -
Avicenne Hospital - Hepatology
Bobigny, France Recruiting -
Avicenne Hospital
Bobigny, France Recruiting -
Haut Lévêque Hospital
Bordeaux, France Recruiting -
Estaing Hospital
Clermont-Ferrand, France Recruiting -
Beaujon Hospital
Clichy, France Recruiting
Show 32 more locations
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Centre Hospitalier Intercommunal
Créteil, France Recruiting -
Henri Mondor Hospital
Créteil, France Recruiting -
Bocage Hospital
Dijon, France Recruiting -
Michallon Hospital
Grenoble, France Recruiting -
Claude Huriez Hospital
Lille, France Recruiting -
Dupuytren Hospital
Limoges, France Recruiting -
Croix Rousse Hospital
Lyon, France Recruiting -
Edouard Herriot Hospital
Lyon, France Recruiting -
Hôpital de la Croix Rousse
Lyon, France Recruiting -
SAint Joseph Hospital
Marseille, France Recruiting -
Saint Eloi Hospital
Montpellier, France Recruiting -
Hotel Dieu Hospital
Nantes, France Recruiting -
Hôtel-Dieu Hospital
Nantes, France Recruiting -
l'Archet 2 Hospital
Nice, France Recruiting -
La Source Hospital
Orléans, France Recruiting -
Bichat-Claude Bernard Hospital
Paris, France Recruiting -
Cochin Hospital
Paris, France Recruiting -
Hôpital Tenon
Paris, France Recruiting -
La Pitié Salpêtrière Hospital
Paris, France Recruiting -
Pitié-Salpêtrière Hospital
Paris, France Recruiting -
Saint Antoine Hospital
Paris, France Recruiting -
Saint Louis Hospital
Paris, France Recruiting -
Saint-Antoine Hospital
Paris, France Recruiting -
Pontchaillou Hospital
Rennes, France Recruiting -
Charles Nicolle Hospital
Rouen, France Recruiting -
Nouvel Hôpital Civil
Strasbourg, France Recruiting -
Hôpital Rangueil
Toulouse, France Recruiting -
Rangueil Hospital
Toulouse, France Recruiting -
Trousseau Hospital
Tours, France Recruiting -
Paul Brousse Hospital
Villejuif, France Recruiting -
Centre Hospitalier de la région annécienne
Annecy, France Not yet recruiting -
Lariboisière Hospital
Paris, France Not yet recruiting
Study contacts
- Study coordinator: COULIBALY Fatoumata
- Email: fatoumata.coulibaly@anrs.fr
- Phone: 0144236110
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AHB-137 for chronic hepatitis B in adults on nucleotide analogue therapy
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-
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AHB-137 for HBeAg-negative chronic hepatitis B in the Asia–Pacific
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.