Burden of Hepatitis D Virus (HDV) Infection in Italy (HDV Describe)

February 4, 2025 updated by: University of Turin, Italy

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.

Study Overview

Status

Completed

Conditions

Chronic Hepatitis D

Study Type

Observational

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Bari, Italy
    - Università degli studi di Bari Aldo Moro
  - Bergamo, Italy
    - Gastroenterology Hepatology and Transplantation, ASST Bergamo
  - Bergamo, Italy
    - Malattie Infettive, ASST Bergamo
  - Bologna, Italy
    - Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
  - Brescia, Italy
    - Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia
  - Caserta, Italy
    - UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano
  - Catania, Italy
    - UOS Epatologia "G. Rodolico-San Marco"
  - Catanzaro, Italy
    - UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"
  - Foggia, Italy
    - Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia
  - Genova, Italy
    - S.C. Malattie Infettive, E.O. Ospedali Galliera
  - Marsala, Italy
    - UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala
  - Messina, Italy
    - A.O.U. Policlinico G. Martino di Messina, Università di Messina
  - Milano, 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
  - Modena, Italy
    - UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio
  - Napoli, 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"
  - Novara, Italy
    - Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale
  - Padova, Italy
    - UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova
  - Palermo, Italy
    - Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo
  - Parma, Italy
    - UOC di Malattie Infettive, Università di Parma
  - Pisa, Italy
    - Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa
  - Reggio Calabria, Italy
    - UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"
  - Roma, Italy
    - Policlinico Gemelli
  - Roma, Italy
    - Ospedale S. Andrea
  - Roma, Italy
    - Malattie Infettive Roma 2
  - Roma, Italy
    - UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani
  - San Giovanni Rotondo, Italy
    - Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza
  - Siracusa, Italy
    - UOC Malattie Infettive
  - Torino, Italy
    - Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
  - Torino, Italy
    - Unit of Gastroenterology, University of Turin
  - Udine, Italy
    - Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine
  - Verona, Italy
    - UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients with chronic hepatitis D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics of HDV-infected patients Time Frame: 1 year	Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus	1 year
Epidemiologic characteristics of HDV-infected patients Time Frame: 1 year	Risk factors for infection. HDV means hepatitis D virus	1 year
Serum alanine aminotransferase concentration values in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Blood platelet count in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Serum albumin concentration values in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Serum total bilirubin concentration values in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Serum HDV RNA levels in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Proportion of HDV genotypes among patients with detectable HDV RNA Time Frame: 1 year	HDV means hepatitis D virus	1 year
Proportion of patients with detectable HBV DNA among seropositive anti-HDV Time Frame: 1 year	HBV means hepatitis B virus. HDV means hepatitis D virus	1 year
Serum HBV DNA levels in HDV-infected patients Time Frame: 1 year	HBV means hepatitis B virus. HDV means hepatitis D virus	1 year
Proportion of HBV genotypes among patients with detectable HBV DNA Time Frame: 1 year	HBV means hepatitis B virus	1 year
HBsAg concentration levels in HDV-infected patients Time Frame: 1 year	HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus	1 year
HBcrAg concentration levels in HDV-infected patients Time Frame: 1 year	HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus	1 year
Proportion of patients with liver cirrhosis among seropositive anti-HDV Time Frame: 1 year	HDV means hepatitis D virus	1 year
Liver stiffness values in HDV-infected patients Time Frame: 1 year	HDV means hepatitis D virus	1 year
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV Time Frame: 1 year	HDV means hepatitis D virus	1 year
Proportion of patients treated with antiviral therapy among seropositive anti-HDV Time Frame: 1 year	HDV means hepatitis D virus	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

Gilead Sciences

Investigators

Principal Investigator: Mario Rizzetto, MD, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

IN-IT-980-6382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.