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NCT02653443 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
A Phase 2 study, sponsored by Cerus Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02653443 is a Phase 2 study that was terminated before completion, run by Cerus Corporation. The registered enrollment target is 14 participants.
The verdict
NCT02653443, a Phase 2 study, was terminated before completion, sponsored by Cerus Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The objective of this study is to test the hypothesis that INTERCEPT Blood System for platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test platelets) stored for 6 or 7 days will be measured in comparison to "fresh" autologous radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will also be assessed.
Interventions
- BIOLOGICAL Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.
- BIOLOGICAL Autologous apheresis Conventional untreated Platelet Components
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02653443
The ClinicalTrials.gov registry entry for NCT02653443 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cerus Corporation, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets. is the first listed.
NCT02653443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02653443 about?
NCT02653443 is a clinical study titled "A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study". The objective of this study is to test the hypothesis that INTERCEPT Blood System for platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of autologous INTERCEPT Blood System f...
What is the current status of trial NCT02653443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-12. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02653443?
The interventions under investigation include: Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets. (BIOLOGICAL), Autologous apheresis Conventional untreated Platelet Components (BIOLOGICAL).
Who is sponsoring clinical trial NCT02653443?
This trial is sponsored by Cerus Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
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