Burden of Hepatitis D Virus (HDV) Infection in Italy
HDV Describe
1 other identifier
observational
515
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2022
CompletedFirst Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
February 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 5, 2025
February 1, 2025
1.9 years
January 11, 2023
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (19)
Demographic characteristics of HDV-infected patients
Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
1 year
Epidemiologic characteristics of HDV-infected patients
Risk factors for infection. HDV means hepatitis D virus
1 year
Serum alanine aminotransferase concentration values in HDV-infected patients
HDV means hepatitis D virus
1 year
Blood platelet count in HDV-infected patients
HDV means hepatitis D virus
1 year
Serum albumin concentration values in HDV-infected patients
HDV means hepatitis D virus
1 year
Serum total bilirubin concentration values in HDV-infected patients
HDV means hepatitis D virus
1 year
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
HDV means hepatitis D virus
1 year
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
HDV means hepatitis D virus
1 year
Serum HDV RNA levels in HDV-infected patients
HDV means hepatitis D virus
1 year
Proportion of HDV genotypes among patients with detectable HDV RNA
HDV means hepatitis D virus
1 year
Proportion of patients with detectable HBV DNA among seropositive anti-HDV
HBV means hepatitis B virus. HDV means hepatitis D virus
1 year
Serum HBV DNA levels in HDV-infected patients
HBV means hepatitis B virus. HDV means hepatitis D virus
1 year
Proportion of HBV genotypes among patients with detectable HBV DNA
HBV means hepatitis B virus
1 year
HBsAg concentration levels in HDV-infected patients
HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
1 year
HBcrAg concentration levels in HDV-infected patients
HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
1 year
Proportion of patients with liver cirrhosis among seropositive anti-HDV
HDV means hepatitis D virus
1 year
Liver stiffness values in HDV-infected patients
HDV means hepatitis D virus
1 year
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
HDV means hepatitis D virus
1 year
Proportion of patients treated with antiviral therapy among seropositive anti-HDV
HDV means hepatitis D virus
1 year
Study Arms (1)
Patients with chronic hepatitis D
Eligibility Criteria
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.
You may qualify if:
- HBsAg-positive subjects
- years or older
- anti-HD-positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turin, Italylead
- Gilead Sciencescollaborator
Study Sites (36)
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
Milan, Italy
Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco
Milan, Italy
UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
Milan, 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
Padua, 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
Ospedale S. Andrea
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
Syracuse, 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
Biospecimen
Serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Rizzetto, MD
University of Turin, Italy
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
February 10, 2023
Study Start
August 24, 2022
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
February 5, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share