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
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Virus Diseases

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