Status:
RECRUITING
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
University of Milan
Parma University Hospital
Conditions:
Hepatitis D
Eligibility:
All Genders
18+ years
Brief Summary
Pharmacological, single-center, non-profit observational study. The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.
Exclusion
- Co-infection with other viruses (HCV, HIV)
- Treatment with immunosuppressive/immunomodulatory drugs
- Other congenital and/or acquired immunodeficiency conditions
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06504485
Start Date
September 1 2024
End Date
December 31 2025
Last Update
May 2 2025
Active Locations (1)
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1
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, Italy, 20122