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Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Università degli Studi di Bari Aldo Moro
Bari, Italy
Gastroenterology Hepatology and Transplantation, ASST Bergamo
Bergamo, Italy
Malattie Infettive, ASST Bergamo
Bergamo, Italy
Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
Bologna, Italy
Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia
Brescia, Italy
UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano
Caserta, Italy
UOS Epatologia "G. Rodolico-San Marco"
Catania, Italy
UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"
Catanzaro, Italy
Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia
Foggia, Italy
S.C. Malattie Infettive, E.O. Ospedali Galliera
Genova, Italy
Start Date
August 24, 2022
Primary Completion Date
June 30, 2024
Completion Date
December 31, 2024
Last Updated
February 5, 2025
515
ACTUAL participants
Lead Sponsor
University of Turin, Italy
Collaborators
NCT05718700
NCT05953545
NCT03099278
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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