Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpress System

NCT ID: NCT06508996

Last Updated: 2024-07-19

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

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Recruitment Status

COMPLETED

Total Enrollment

1012 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-06

Study Completion Date

2024-06-06

Brief Summary

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A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.

Detailed Description

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Whole blood specimens were collected from consented individuals with signs and symptoms and/or individuals at-risk of HCV infection, irrespective of HCV antibody status at a single timepoint.

Conditions

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HCV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Capillary whole blood

Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection

Xpert HCV

Intervention Type DIAGNOSTIC_TEST

Detection of HCV RNA by Xpert HCV test

Interventions

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Xpert HCV

Detection of HCV RNA by Xpert HCV test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Participant was ≥18 years old
* Participant was not on treatment at time of enrollment based on review of medical records or self-reported
* Participant had signs and symptoms and/or is considered at-risk of HCV infection

Exclusion Criteria

* Clinician assessed that the participant was not suitable for inclusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

Cepheid

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Havens

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky College of Medicine

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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293C

Identifier Type: -

Identifier Source: org_study_id

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