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

November 28, 2023 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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy
        • Not yet recruiting
        • Università degli Studi di Bari Aldo Moro
        • Contact:
          • Annalisa Saracino
      • Bergamo, Italy
        • Recruiting
        • Gastroenterology Hepatology and Transplantation, ASST Bergamo
        • Contact:
          • Stefano Fagiuoli
      • Bergamo, Italy
        • Recruiting
        • Malattie Infettive, ASST Bergamo
        • Contact:
          • Marco Rizzi
      • Bologna, Italy
        • Recruiting
        • Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
        • Contact:
          • Gabriella Verucchi
      • Brescia, Italy
        • Not yet recruiting
        • Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia
        • Contact:
          • Francesco Castelli
      • Caserta, Italy
        • Not yet recruiting
        • UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano
        • Contact:
          • Vincenzo Messina
      • Catania, Italy
        • Not yet recruiting
        • UOS Epatologia "G. Rodolico-San Marco"
        • Contact:
          • Gaetano Bertino
      • Catanzaro, Italy
        • Not yet recruiting
        • UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"
        • Contact:
          • Vincenzo Pisani
      • Foggia, Italy
        • Not yet recruiting
        • Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia
        • Contact:
          • Teresa Santantonio
      • Genova, Italy
        • Not yet recruiting
        • S.C. Malattie Infettive, E.O. Ospedali Galliera
        • Contact:
          • Emanuele Pontali
      • Marsala, Italy
        • Not yet recruiting
        • UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala
        • Contact:
          • Pietro Colletti
      • Messina, Italy
        • Not yet recruiting
        • A.O.U. Policlinico G. Martino di Messina, Università di Messina
        • Contact:
          • Giovanni Raimondo
      • Milano, Italy
        • Not yet recruiting
        • Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Massimo Puoti
      • Milano, Italy
        • Recruiting
        • Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco
        • Contact:
          • Giuliano Rizzardini
      • Milano, Italy
        • Recruiting
        • UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
        • Contact:
          • Pietro Lampertico
      • Modena, Italy
        • Not yet recruiting
        • UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio
        • Contact:
          • Pietro Andreone
      • Napoli, Italy
        • Not yet recruiting
        • Dipartimento di Malattie Infettive, Ospedale D. Cotugno
        • Contact:
          • Antonio Izzi
      • Napoli, Italy
        • Recruiting
        • Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli"
        • Contact:
          • Alessandro Federico
      • Napoli, Italy
        • Recruiting
        • Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II
        • Contact:
          • Filomena Morisco
      • Napoli, Italy
        • Not yet recruiting
        • Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli"
        • Contact:
          • Aldo Marrone
      • Novara, Italy
        • Recruiting
        • Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale
        • Contact:
          • Mario Pirisi
      • Padova, Italy
        • Not yet recruiting
        • UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova
        • Contact:
          • Anna Maria Cattelan
      • Palermo, Italy
        • Not yet recruiting
        • Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo
        • Contact:
          • Antonio Craxì
      • Parma, Italy
        • Not yet recruiting
        • UOC di Malattie Infettive, Università di Parma
        • Contact:
          • Carlo Ferrari
      • Pisa, Italy
        • Recruiting
        • Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa
        • Contact:
          • Maurizia Rossana Brunetto
      • Reggio Calabria, Italy
        • Not yet recruiting
        • UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"
        • Contact:
          • Giuseppe Foti
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Gemelli
        • Contact:
          • Antonio Gasbarrini
      • Roma, Italy
        • Not yet recruiting
        • Malattie Infettive Roma 2
        • Contact:
          • Massimo Andreoni
      • Roma, Italy
        • Not yet recruiting
        • Ospedale S. Andrea
        • Contact:
          • Massimo Marignani
      • Roma, Italy
        • Not yet recruiting
        • UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani
        • Contact:
          • Giampiero D'Offizi
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza
        • Contact:
          • Grazia Anna Niro
      • Siracusa, Italy
        • Not yet recruiting
        • UOC Malattie Infettive
        • Contact:
          • Marco Distefano
      • Torino, Italy
        • Recruiting
        • Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
        • Contact:
          • Giuseppe Cariti
      • Torino, Italy
        • Recruiting
        • Unit of Gastroenterology, University of Turin
        • Contact:
          • Alessia Ciancio
      • Udine, Italy
        • Not yet recruiting
        • Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine
        • Contact:
          • Pierluigi Toniutto
      • Verona, Italy
        • Not yet recruiting
        • UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
          • Giada Carolo

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

No

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

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 (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Chronic Hepatitis D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe