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NCT05813691 Clinical Trial

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

Hepatitis C Clinical Trial

— ERADIcATE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05813691
Other study ID # 5494
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 10, 2023
Est. completion date April 10, 2025

Study information
Verified date April 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4000
Est. completion date April 10, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers
Gender All
Age group 54 Years to 120 Years
Eligibility Inclusion Criteria: - Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli Exclusion Criteria: - Patients born after january 1st 1968 - Known infection of hepatitis C virus - Previous treatment against hepatitis C virus

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Meridan Bioscience Point of Care test against HCV antibodies
Point of care evaluation of antibodies against HCV obtaining a drop of capillary blood via puncture of the fingertip. If antibodies were detected, HCV RNA assay will be performed.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of antibodies against hepatitis C virus in cohort population Evaluation of prevalence of antibodies against HCV in patients referred to any department of Policlinico Gemelli born before January 1st 1968 24 months
Secondary Characteristics of population 24 months
Secondary Prevalence of patients with a confirmed chronic HCV infection who are referred to Hepatology Outpatient clinic 24 months
Secondary Prevalence of patients with a confirmed chronic HCV infection who are treated with direct antiviral agents 24 months
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