Phase 2
N=15
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
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04022889 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Post Infusion Recovery of Test Platelets at End of Storage (Day 7) — 39.5; 57.8; 39.1; 60.4 percentage of infused platelets
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INTERCEPT Treated Platelets (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cerus Corporation
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Infusion Recovery of Test Platelets at End of Storage (Day 7) |
39.5; 57.8; 39.1; 60.4; 37.6; 56.8 | — |
| PRIMARY Post Infusion Survival of Test Platelets at End of Storage |
150.1; 208.9; 143.2; 202.9; 151.4; 209.6 | — |
| SECONDARY Platelet Dose in Test Component |
12; 13; 22 | — |
| SECONDARY Platelet Yield Retention |
12; 12; 22 | — |
| SECONDARY pH 22°C |
13; 13; 23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18 years, of either gender.
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam).
- Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet donation. Travel, tattoos/piercings and/or male to male sexual contact deferrals do not apply.
- Complete blood count (CBC) and serum chemistry values within established reference ranges or within guidelines as above.
- Pre-donation platelet count of more than 150×10^9 platelets/ L.
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
- Signed and dated informed consent form.
Exclusion Criteria
- For participation in Stage 2, received any previous infusion in this study.
- Clinically significant acute or chronic disease (as determined by the Investigator).
- Pregnant or nursing females.
- Subjects of childbearing potential not using effective contraception.
- Disease states or conditions that preclude apheresis platelet donation per AABB reference standards.
- Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents (or other drugs affecting platelet viability within 3 days of apheresis (e.g., ibuprofen or other NSAIDs).
- Subject received platelet inhibitors within 14 days of donation (e.g., clopidogrel, ticlopidine, amphetamines (e.g., Adderall, Dexedrine)).
- Subjects with positive cocaine and/or amphetamine results from urine drug screen.
- Splenectomized subjects.
- History of known hypersensitivity to indium or chromium.
- Has received an investigational drug within the past 28 days
Data sourced from ClinicalTrials.gov (NCT04022889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.