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NCT04054661 · ClinicalTrials.gov registry record · NA
Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood
A NA study of G6PD Deficiency, sponsored by PATH.
- Completed
- Registry status
- NA
- Development phase
- 229
- Enrollment target
- 1
- Study location
NCT04054661: Completed NA study of G6PD Deficiency, sponsored by PATH.
NCT04054661 is a NA study of G6PD Deficiency that has completed, run by PATH. The registered enrollment target is 229 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054661, a NA study of G6PD Deficiency, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- NA
- Development phase
- 229 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.
Primary Outcome
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test. Diagnostic sensitivity of the SD Biosensor STANDARD G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positiv
Conditions Studied
Interventions
- DIAGNOSTIC_TEST SD Biosensor STANDARD G6PD Test
- DIAGNOSTIC_TEST Pointe Scientific Test Kit
- DIAGNOSTIC_TEST HemoCue System
Study Locations (1)
Pennsylvania
- BSC corporation - Reading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2019-08-12 |
| Est. Completion | 2020-01-31 |
| Phase | NA |
What the finished NCT04054661 record still lists
NCT04054661 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 1 condition, with G6PD Deficiency appearing as the primary indexed condition, and to 3 interventions - of which SD Biosensor STANDARD G6PD Test is the first listed.
NCT04054661 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04054661 about?
NCT04054661 is a clinical study titled "Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood". The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.
What is the current status of trial NCT04054661?
This trial is currently completed. It is a NA study. The enrollment target is 229 participants. The study started on 2019-08-12. Estimated completion is 2020-01-31.
What conditions does trial NCT04054661 study?
This clinical trial studies the following conditions: G6PD Deficiency.
What interventions are being tested in trial NCT04054661?
The interventions under investigation include: SD Biosensor STANDARD G6PD Test (DIAGNOSTIC_TEST), Pointe Scientific Test Kit (DIAGNOSTIC_TEST), HemoCue System (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04054661?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04054661 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04054661's enrollment target sits among peer trials
229 468th of 2000 higher than 1,533 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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