Epidemiology of Occult Hepatitis C Virus Infection in Patients Born Before 1969 in the Hospital Setting: a Spontaneous Opportunistic Screening Initiative.
ERADIcATE
1 other identifier
observational
4,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2023
CompletedStudy Start
First participant enrolled
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2025
CompletedApril 14, 2023
April 1, 2023
1.8 years
April 2, 2023
April 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
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.
Eligibility Criteria
Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
You may qualify if:
- Patients born before January 1st 1968 who lived in Italy referred to any departments of the Policlinico A. Gemelli
You may not qualify if:
- Patients born after january 1st 1968
- Known infection of hepatitis C virus
- Previous treatment against hepatitis C virus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
April 2, 2023
First Posted
April 14, 2023
Study Start
April 10, 2023
Primary Completion
January 31, 2025
Study Completion
April 10, 2025
Last Updated
April 14, 2023
Record last verified: 2023-04