Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpres... | NCT06508996

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

NCT06508996

Sponsor

Cepheid

Status

Completed

Last Update Posted

Jul 19, 2024Actual

Enrollment

1,012Actual

Phase

Not provided

Conditions

Interventions

Xpert HCV

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2024Actual

Primary Completion Date

May 10, 2024Actual

Completion Date

Jun 6, 2024Actual

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Jul 12, 2024

First Posted Date

Jul 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2024

Last Update Posted Date

Jul 19, 2024Actual

Name	Class
Emory University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,012Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Capillary whole blood		Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection	Diagnostic Test: Xpert HCV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Xpert HCV	Diagnostic Test	Detection of HCV RNA by Xpert HCV test	Capillary whole blood

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Agreement compared to Patient infected status (PIS)	Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Specimens collected from individuals showing signs and symptoms and/or at risk of HCV infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Havens	University of Kentucky College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40508	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided