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NCT06380166 · ClinicalTrials.gov registry record
Hepatitis C Lab Testing Comparison Study
A clinical trial, sponsored by HealthPartners Institute.
- Terminated
- Registry status
- 1
- Enrollment target
NCT06380166: Clinical Trial study, sponsored by HealthPartners Institute.
NCT06380166 is a clinical trial that was terminated before completion, run by HealthPartners Institute. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06380166 was terminated before completion, sponsored by HealthPartners Institute.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories.
Primary Outcome
Determine the 48-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at ambient temperatures (20.0-25.0 C) and collected from patients with detectable HCV VLs who completed standard of care Hepatitis C RNA Quantitative testing within the prior 2 weeks. Determine the 144-hour reproducibility of HCV core antigen measurements in serum and plasma specimens stored at refrigerated temperatures (2.0-8.0 C) and collected from patients with detectable HCV VLs who c
Interventions
- DIAGNOSTIC_TEST Hepatitis C core antigen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-07-24 |
| Est. Completion | 2024-12-06 |
Why NCT06380166 stopped before completion
NCT06380166 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Hepatitis C core antigen is the first listed.
NCT06380166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06380166 about?
NCT06380166 is a clinical study titled "Hepatitis C Lab Testing Comparison Study". Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially...
What is the current status of trial NCT06380166?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2024-07-24. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT06380166?
The interventions under investigation include: Hepatitis C core antigen (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06380166?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
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