Clinical trial Recruiting at 36 sites Observational Ages 18 and up

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.

More Hepatitis B, Chronic trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorANRS, Emerging Infectious Diseases
Government
Locations38 sites (Angers and 37 other locations)
StatusRecruiting
StartedFebruary 19, 2020
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedFebruary 5, 2025
Trial IDNCT04166266 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.