HCVNCT06508996
Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpress System
An observational study of HCV, run by Cepheid at 1 site in United States.
Trial summary
A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- What is being tested?
- Xpert HCV
- How many people
- 1,012 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 6 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Specimens collected from individuals showing signs and symptoms and/or at risk of HCV infection
Who may be able to join
- 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
Who cannot join
- Clinician assessed that the participant was not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System
A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.
Read the 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.
- Conditions
- HCV
- Being tested
- Xpert HCV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert HCVDiagnostic test
Detection of HCV RNA by Xpert HCV test
| Study group | Role | What they receive |
|---|---|---|
| Capillary whole blood | Capillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection Receives: Diagnostic Test: Xpert HCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Agreement compared to Patient infected status (PIS)
Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start6 Feb 2024
- Primary completion10 May 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Jennifer Havens, Principal investigator, University of Kentucky College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508996
- Sponsor's protocol ID
- 293C
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Havens JR, Fluker SA, Schimmel J, McCrary LM, Miller LS, Udo T, Manabe YC, Luetkemeyer A, Burkholder G, Moon AM, Chastain CA, Price JC, Cafardi J, Gallegos-Orozco JF, Young BA, Young J, Aparicio C, Song Y, Lai E, Louw GE. Performance Evaluation of the Xpert(R) HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States. Clin Infect Dis. 2026 Jul 23;83(1):e71-e78. doi: 10.1093/cid/ciag173.
PubMed 41823658
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System
- ClinicalTrials.gov ID
- NCT06508996
- Acronym / sponsor ID
- 293C
- Conditions
- HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Collaborators
- Emory University
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capillary whole blood | – | Diagnostic Test: Xpert HCVCapillary whole blood from individuals with signs and symptoms and/or at-risk of HCV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Specimens collected from individuals showing signs and symptoms and/or at risk of HCV infection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Clinician assessed that the participant was not suitable for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert HCVDetection of HCV RNA by Xpert HCV test | Diagnostic test | Capillary whole blood |
Primary outcome
Percent Agreement compared to Patient infected status (PIS)
Time frame: 1 day
Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 41823658Havens JR, Fluker SA, Schimmel J, McCrary LM, Miller LS, Udo T, Manabe YC, Luetkemeyer A, Burkholder G, Moon AM, Chastain CA, Price JC, Cafardi J, Gallegos-Orozco JF, Young BA, Young J, Aparicio C, Song Y, Lai E, Louw GE. Performance Evaluation of the Xpert(R) HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States. Clin Infect Dis. 2026 Jul 23;83(1):e71-e78. doi: 10.1093/cid/ciag173.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Havens principal investigator
University of Kentucky College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCV, run by Cepheid at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Agreement compared to Patient infected status (PIS) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.