ERADIcATE: Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05813691

Collaborator

(none)

4,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this monocentric prospective observational study is to evaluate the prevalence of unknown hepatitis C virus chronic infection in general population born before january 1st 1968 in Italy.

The main questions it aims to answer are:

what is the prevalence of hepatits C virus infection in general population born before January 1st, 1968? What rare the characteristics of these patients compared to the general population? What is the prevalence of patients tested HCV positive who are referred to the Hepatology Outpatient Clinic for further evaluation? What is the prevalence of patients with HCV infection detected during the study and treated with direct antiviral agents during follow up?

Participants will be tested with a point of care screening test (Meridian, Bioscience) able to detect anti-HCV antibodies to detect the presence of antibodies against HCV.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic Hepatitis C Hepatitis	Diagnostic Test: Meridan Bioscience Point of Care test against HCV antibodies

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.

Anticipated Study Start Date :

Apr 10, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Apr 10, 2025

Outcome Measures

Primary Outcome Measures

prevalence of antibodies against hepatitis C virus in cohort population [24 months]
Evaluation of prevalence of antibodies against HCV in patients referred to any department of Policlinico Gemelli born before January 1st 1968

Secondary Outcome Measures

Characteristics of population [24 months]
Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic [24 months]
Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents [24 months]