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Observational study of patients co-infected with Hepatitis B and Delta viruses

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

Observational ANRS, Emerging Infectious Diseases · NCT04166266

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 typeObservational
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorANRS, Emerging Infectious Diseases Government
Locations38 sites (Angers and 37 other locations)
Trial IDNCT04166266 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with chronic hepatitis D infection who can provide informed consent.

Not a fit: Patients currently participating in other biomedical research or those with predictable follow-up difficulties may not benefit from this study.

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 performed: While there have been studies on hepatitis infections, this specific observational approach for co-infected patients is relatively novel.

Eligibility criteria

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 this trial is running

Angers and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatitis D, ChronicHepatitis B, Chronicsafetyefficacyevolutiontreatment
Last reviewed 2026-06-13 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.