NCT05813691

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 54 Years – 120 Years
• Healthy volunteers: —

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.

Conditions

• Hepatitis C, Chronic
• Hepatitis C
• Hepatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-10
• Primary completion: 2025-01-31
• Completion: 2025-04-10
• First posted: 2023-04-14
• Last updated: 2023-04-14