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NCT04022889 · ClinicalTrials.gov registry record · Phase 2
In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
A Phase 2 study, sponsored by Cerus Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT04022889: Completed Phase 2 study, sponsored by Cerus Corporation.
NCT04022889 is a Phase 2 study that has completed, run by Cerus Corporation. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04022889, a Phase 2 study, has completed, sponsored by Cerus Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and survival of autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to "fresh" autologous radiolabeled platelets (Control) according to FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol. A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration (BEST) or a variation of the BEST procedure (referred to as Variant 1) in Stage 1 of this study protocol. Cerus has demonstrated that the Variant 1 method, which does not incorporate an initial soft spin in the presence of ACD A, results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes.
Primary Outcome
Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Interventions
- DEVICE INTERCEPT Treated Platelets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2021-04-17 |
| Phase | Phase 2 |
What the finished NCT04022889 record still lists
NCT04022889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which INTERCEPT Treated Platelets is the first listed.
NCT04022889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04022889 about?
NCT04022889 is a clinical study titled "In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days". The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and survival of autologous radi...
What is the current status of trial NCT04022889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2019-11-05. Estimated completion is 2021-04-17.
What interventions are being tested in trial NCT04022889?
The interventions under investigation include: INTERCEPT Treated Platelets (DEVICE).
Who is sponsoring clinical trial NCT04022889?
This trial is sponsored by Cerus Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04022889's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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