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NCT04862065 · ClinicalTrials.gov registry record · NA
Alinity s Anti-HCV II - Clinical Evaluation Protocol
A NA study of Healthy, sponsored by Abbott Transfusion Medicine.
- Completed
- Registry status
- NA
- Development phase
- 16,388
- Enrollment target
- 4
- Study locations
NCT04862065: Completed NA study of Healthy, sponsored by Abbott Transfusion Medicine.
NCT04862065 is a NA study of Healthy that has completed, run by Abbott Transfusion Medicine. The registered enrollment target is 16,388 participants, above the 632-participant average among 1,090 other Healthy trials with a reported enrollment target (2493% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862065, a NA study of Healthy, has completed, sponsored by Abbott Transfusion Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 16,388 participants
- Enrollment target
- 4
- Study locations
Study Summary
The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food and Drug Administration (FDA) licensed Alinity s Anti-HCV assay as the comparator method. The data will be used to support regulatory submissions and/or publications.
Conditions Studied
Interventions
- DEVICE Alinity s Anti-HCV II
Study Locations (4)
Minnesota
- Innovative Blood Resources - Saint Paul
Tennessee
- CSL Plasma Inc. - Knoxville
Texas
- QualTex Laboratories - San Antonio
Washington
- Bloodworks Northwest - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,388 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2021-08-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04862065
The ClinicalTrials.gov registry entry for NCT04862065 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16,388 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 632-participant average among 1,090 other Healthy trials with a reported enrollment target (2493% higher). The listed sponsor is Abbott Transfusion Medicine, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Alinity s Anti-HCV II is the first listed.
NCT04862065 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Minnesota, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT04862065 about?
NCT04862065 is a clinical study titled "Alinity s Anti-HCV II - Clinical Evaluation Protocol". The objective of this study is to demonstrate the performance and intended use of the Alinity s Anti-HCV II investigational assay in a donor screening environment using clinical samples to evaluate assay performance. The Alinity s Anti-HCV II assay performance will be evaluated utilizing the Food an...
What is the current status of trial NCT04862065?
This trial is currently completed. It is a NA study. The enrollment target is 16,388 participants. The study started on 2021-04-19. Estimated completion is 2021-08-05.
What conditions does trial NCT04862065 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04862065?
The interventions under investigation include: Alinity s Anti-HCV II (DEVICE).
Who is sponsoring clinical trial NCT04862065?
This trial is sponsored by Abbott Transfusion Medicine, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862065 being conducted?
This trial has 4 study locations across Minnesota, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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