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

NCT ID: NCT05813691

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-10

Study Completion Date

2025-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic Hepatitis C Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

54 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ponziani Francesca Romana

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5494

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.