Burden of Hepatitis D Virus (HDV) Infection in Italy
- Conditions
- Chronic Hepatitis D
- Registration Number
- NCT05723068
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
- HBsAg-positive subjects
- 18 years or older
- anti-HD-positive
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demographic characteristics of HDV-infected patients 1 year Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
Serum alanine aminotransferase concentration values in HDV-infected patients 1 year HDV means hepatitis D virus
Epidemiologic characteristics of HDV-infected patients 1 year Risk factors for infection. HDV means hepatitis D virus
Blood platelet count in HDV-infected patients 1 year HDV means hepatitis D virus
Serum albumin concentration values in HDV-infected patients 1 year HDV means hepatitis D virus
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients 1 year HDV means hepatitis D virus
Serum HBV DNA levels in HDV-infected patients 1 year HBV means hepatitis B virus. HDV means hepatitis D virus
Liver stiffness values in HDV-infected patients 1 year HDV means hepatitis D virus
Serum total bilirubin concentration values in HDV-infected patients 1 year HDV means hepatitis D virus
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients 1 year HDV means hepatitis D virus
Serum HDV RNA levels in HDV-infected patients 1 year HDV means hepatitis D virus
Proportion of HDV genotypes among patients with detectable HDV RNA 1 year HDV means hepatitis D virus
HBsAg concentration levels in HDV-infected patients 1 year HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV 1 year HDV means hepatitis D virus
Proportion of patients treated with antiviral therapy among seropositive anti-HDV 1 year HDV means hepatitis D virus
Proportion of patients with detectable HBV DNA among seropositive anti-HDV 1 year HBV means hepatitis B virus. HDV means hepatitis D virus
Proportion of HBV genotypes among patients with detectable HBV DNA 1 year HBV means hepatitis B virus
Proportion of patients with liver cirrhosis among seropositive anti-HDV 1 year HDV means hepatitis D virus
HBcrAg concentration levels in HDV-infected patients 1 year HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Ospedale S. Andrea
🇮🇹Roma, Italy
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
UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala
🇮🇹Marsala, Italy
A.O.U. Policlinico G. Martino di Messina, Università di Messina
🇮🇹Messina, Italy
Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco
🇮🇹Milano, Italy
UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
🇮🇹Milano, Italy
UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio
🇮🇹Modena, Italy
Dipartimento di Malattie Infettive, Ospedale D. Cotugno
🇮🇹Napoli, Italy
Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II
🇮🇹Napoli, Italy
Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale
🇮🇹Novara, Italy
UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova
🇮🇹Padova, Italy
Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo
🇮🇹Palermo, Italy
UOC di Malattie Infettive, Università di Parma
🇮🇹Parma, Italy
Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa
🇮🇹Pisa, Italy
UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"
🇮🇹Reggio Calabria, Italy
Malattie Infettive Roma 2
🇮🇹Roma, Italy
Policlinico Gemelli
🇮🇹Roma, Italy
UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani
🇮🇹Roma, Italy
Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
UOC Malattie Infettive
🇮🇹Siracusa, Italy
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
Unit of Gastroenterology, University of Turin
🇮🇹Torino, Italy
Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine
🇮🇹Udine, Italy
UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy