Burden of Hepatitis D Virus (HDV) Infection in Italy

Chronic Hepatitis D Clinical Trial

— HDV Describe  

Official title:

Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723068
• Other study ID #: IN-IT-980-6382
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of Turin, Italy
• Contact: Gian Paolo Caviglia, PhD
• Phone: +39 0116333532
• Email: gianpaolo.caviglia[@]unito.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HBsAg-positive subjects

• 18 years or older

• anti-HD-positive

Related Conditions & MeSH terms

• Chronic Hepatitis D
• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic

Locations

Country	Name	City	State
Italy	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	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	Milano
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	Padova
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	Siracusa
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Gilead Sciences

Country where clinical trial is conducted

Italy, 

Outcome

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