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

Sponsor
University of Turin, Italy (Other)
Overall Status
Recruiting
CT.gov ID
NCT05723068
Collaborator
Gilead Sciences (Industry)
500
Enrollment
36
Locations
10.2
Anticipated Duration (Months)
13.9
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
    Actual Study Start Date :
    Aug 24, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with chronic hepatitis D

    Outcome Measures

    Primary Outcome Measures

    1. Demographic characteristics of HDV-infected patients [1 year]

      Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus

    2. Epidemiologic characteristics of HDV-infected patients [1 year]

      Risk factors for infection. HDV means hepatitis D virus

    3. Serum alanine aminotransferase concentration values in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    4. Blood platelet count in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    5. Serum albumin concentration values in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    6. Serum total bilirubin concentration values in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    7. Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    8. Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients [1 year]

      HDV means hepatitis D virus

    9. Serum HDV RNA levels in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    10. Proportion of HDV genotypes among patients with detectable HDV RNA [1 year]

      HDV means hepatitis D virus

    11. Proportion of patients with detectable HBV DNA among seropositive anti-HDV [1 year]

      HBV means hepatitis B virus. HDV means hepatitis D virus

    12. Serum HBV DNA levels in HDV-infected patients [1 year]

      HBV means hepatitis B virus. HDV means hepatitis D virus

    13. Proportion of HBV genotypes among patients with detectable HBV DNA [1 year]

      HBV means hepatitis B virus

    14. HBsAg concentration levels in HDV-infected patients [1 year]

      HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus

    15. HBcrAg concentration levels in HDV-infected patients [1 year]

      HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus

    16. Proportion of patients with liver cirrhosis among seropositive anti-HDV [1 year]

      HDV means hepatitis D virus

    17. Liver stiffness values in HDV-infected patients [1 year]

      HDV means hepatitis D virus

    18. Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV [1 year]

      HDV means hepatitis D virus

    19. Proportion of patients treated with antiviral therapy among seropositive anti-HDV [1 year]

      HDV means hepatitis D virus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HBsAg-positive subjects

    • 18 years or older

    • anti-HD-positive

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Università degli Studi di Bari Aldo Moro Bari Italy
    2 Gastroenterology Hepatology and Transplantation, ASST Bergamo Bergamo Italy
    3 Malattie Infettive, ASST Bergamo Bergamo Italy
    4 Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna Bologna Italy
    5 Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia Brescia Italy
    6 UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano Caserta Italy
    7 UOS Epatologia "G. Rodolico-San Marco" Catania Italy
    8 UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini" Catanzaro Italy
    9 Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia Foggia Italy
    10 S.C. Malattie Infettive, E.O. Ospedali Galliera Genova Italy
    11 UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala Marsala Italy
    12 A.O.U. Policlinico G. Martino di Messina, Università di Messina Messina Italy
    13 Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda Milano Italy
    14 Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco Milano Italy
    15 UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano Milano Italy
    16 UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio Modena Italy
    17 Dipartimento di Malattie Infettive, Ospedale D. Cotugno Napoli Italy
    18 Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli" Napoli Italy
    19 Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II Napoli Italy
    20 Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli" Napoli Italy
    21 Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale Novara Italy
    22 UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova Padova Italy
    23 Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo Palermo Italy
    24 UOC di Malattie Infettive, Università di Parma Parma Italy
    25 Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa Pisa Italy
    26 UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli" Reggio Calabria Italy
    27 Malattie Infettive Roma 2 Roma Italy
    28 Ospedale S. Andrea Roma Italy
    29 Policlinico Gemelli Roma Italy
    30 UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani Roma Italy
    31 Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo Italy
    32 UOC Malattie Infettive Siracusa Italy
    33 Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia Torino Italy
    34 Unit of Gastroenterology, University of Turin Torino Italy
    35 Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine Udine Italy
    36 UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona Verona Italy

    Sponsors and Collaborators

    • University of Turin, Italy
    • Gilead Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Turin, Italy
    ClinicalTrials.gov Identifier:
    NCT05723068
    Other Study ID Numbers:
    • IN-IT-980-6382
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis D
    Hepatitis D, Chronic
    Hepatitis

    Study Results

    No Results Posted as of Feb 10, 2023