Clinical trial NCT05723068: Burden of Hepatitis D Virus (HDV) Infection in Italy
Official title: Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis D
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2023-02-10
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited in a Country-wide coordinated network of national medical centers. The network will include hepatology, infectious disease and internal medicine centers that historically care for patients with viral liver disease, located in the 12 major regions of 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.


Eligibility criteria: Inclusion Criteria:

* HBsAg-positive subjects
* 18 years or older
* anti-HD-positive

Primary outcomes:
measure: Demographic characteristics of HDV-infected patients
timeFrame: 1 year
measure: Epidemiologic characteristics of HDV-infected patients
timeFrame: 1 year
measure: Serum alanine aminotransferase concentration values in HDV-infected patients
timeFrame: 1 year
measure: Blood platelet count in HDV-infected patients
timeFrame: 1 year
measure: Serum albumin concentration values in HDV-infected patients
timeFrame: 1 year
measure: Serum total bilirubin concentration values in HDV-infected patients
timeFrame: 1 year
measure: Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
timeFrame: 1 year
measure: Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
timeFrame: 1 year
measure: Serum HDV RNA levels in HDV-infected patients
timeFrame: 1 year
measure: Proportion of HDV genotypes among patients with detectable HDV RNA
timeFrame: 1 year
measure: Proportion of patients with detectable HBV DNA among seropositive anti-HDV
timeFrame: 1 year
measure: Serum HBV DNA levels in HDV-infected patients
timeFrame: 1 year
measure: Proportion of HBV genotypes among patients with detectable HBV DNA
timeFrame: 1 year
measure: HBsAg concentration levels in HDV-infected patients
timeFrame: 1 year
measure: HBcrAg concentration levels in HDV-infected patients
timeFrame: 1 year
measure: Proportion of patients with liver cirrhosis among seropositive anti-HDV
timeFrame: 1 year
measure: Liver stiffness values in HDV-infected patients
timeFrame: 1 year
measure: Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
timeFrame: 1 year
measure: Proportion of patients treated with antiviral therapy among seropositive anti-HDV
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Università degli Studi di Bari Aldo Moro
city: Bergamo
country: Italy
facility: Gastroenterology Hepatology and Transplantation, ASST Bergamo
city: Bergamo
country: Italy
facility: Malattie Infettive, ASST Bergamo
city: Bologna
country: Italy
facility: Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
city: Brescia
country: Italy
facility: Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia
city: Caserta
country: Italy
facility: UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano
city: Catania
country: Italy
facility: UOS Epatologia "G. Rodolico-San Marco"
city: Catanzaro
country: Italy
facility: UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"
city: Foggia
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia
city: Genova
country: Italy
facility: S.C. Malattie Infettive, E.O. Ospedali Galliera
city: Marsala
country: Italy
facility: UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala
city: Messina
country: Italy
facility: A.O.U. Policlinico G. Martino di Messina, Università di Messina
city: Milano
country: Italy
facility: Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco
city: Milano
country: Italy
facility: UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
city: Modena
country: Italy
facility: UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio
city: Napoli
country: Italy
facility: Dipartimento di Malattie Infettive, Ospedale D. Cotugno
city: Napoli
country: Italy
facility: Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli"
city: Napoli
country: Italy
facility: Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II
city: Napoli
country: Italy
facility: Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli"
city: Novara
country: Italy
facility: Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale
city: Padova
country: Italy
facility: UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova
city: Palermo
country: Italy
facility: Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo
city: Parma
country: Italy
facility: UOC di Malattie Infettive, Università di Parma
city: Pisa
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa
city: Reggio Calabria
country: Italy
facility: UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"
city: Roma
country: Italy
facility: Malattie Infettive Roma 2
city: Roma
country: Italy
facility: Ospedale S. Andrea
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Roma
country: Italy
facility: UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani
city: San Giovanni Rotondo
country: Italy
facility: Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza
city: Siracusa
country: Italy
facility: UOC Malattie Infettive
city: Torino
country: Italy
facility: Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
city: Torino
country: Italy
facility: Unit of Gastroenterology, University of Turin
city: Udine
country: Italy
facility: Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine
city: Verona
country: Italy
facility: UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
affiliation: University of Turin, Italy
name: Mario Rizzetto, MD
role: PRINCIPAL_INVESTIGATOR
References: