Burden of Hepatitis D Virus (HDV) Infection in Italy

NCT ID: NCT05723068

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Chronic Hepatitis D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chronic hepatitis D

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HBsAg-positive subjects
* 18 years or older
* anti-HD-positive
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mario Rizzetto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

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Università degli Studi di Bari Aldo Moro

Bari, , Italy

Site Status

Gastroenterology Hepatology and Transplantation, ASST Bergamo

Bergamo, , Italy

Site Status

Malattie Infettive, ASST Bergamo

Bergamo, , Italy

Site Status

Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna

Bologna, , Italy

Site Status

Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia

Brescia, , Italy

Site Status

UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano

Caserta, , Italy

Site Status

UOS Epatologia "G. Rodolico-San Marco"

Catania, , Italy

Site Status

UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"

Catanzaro, , Italy

Site Status

Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia

Foggia, , Italy

Site Status

S.C. Malattie Infettive, E.O. Ospedali Galliera

Genova, , Italy

Site Status

UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala

Marsala, , Italy

Site Status

A.O.U. Policlinico G. Martino di Messina, Università di Messina

Messina, , Italy

Site Status

Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco

Milan, , Italy

Site Status

UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano

Milan, , Italy

Site Status

UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio

Modena, , Italy

Site Status

Dipartimento di Malattie Infettive, Ospedale D. Cotugno

Napoli, , Italy

Site Status

Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli"

Napoli, , Italy

Site Status

Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II

Napoli, , Italy

Site Status

Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli"

Napoli, , Italy

Site Status

Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale

Novara, , Italy

Site Status

UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova

Padua, , Italy

Site Status

Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo

Palermo, , Italy

Site Status

UOC di Malattie Infettive, Università di Parma

Parma, , Italy

Site Status

Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa

Pisa, , Italy

Site Status

UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"

Reggio Calabria, , Italy

Site Status

Malattie Infettive Roma 2

Roma, , Italy

Site Status

Ospedale S. Andrea

Roma, , Italy

Site Status

Policlinico Gemelli

Roma, , Italy

Site Status

UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani

Roma, , Italy

Site Status

Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

UOC Malattie Infettive

Syracuse, , Italy

Site Status

Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia

Torino, , Italy

Site Status

Unit of Gastroenterology, University of Turin

Torino, , Italy

Site Status

Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine

Udine, , Italy

Site Status

UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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IN-IT-980-6382

Identifier Type: -

Identifier Source: org_study_id

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