N/A
N=90
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Chikungunya Virus · Dengue Virus
Bottom Line
View on ClinicalTrials.gov: NCT02305732 ↗Enrolled (actual)
90
Serious AEs
21.1%
Results posted
Oct 2018
Primary outcome: Primary: The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets. — 256 Platelet Components
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- INTERCEPT Platelets (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Cerus Corporation
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets. |
256 | — |
| PRIMARY The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection |
— | — |
| PRIMARY The Proportion of Patients With Any Transfusion Reactions |
3 | — |
| PRIMARY The Proportion of Patients With Any Unrelated Adverse Event |
26 | — |
| PRIMARY The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event |
50 | — |
Summary
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).
The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.
Eligibility Criteria
Inclusion Criteria
- Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
- Patient population as defined by each Investigator and their institutional review board (IRB).
- Patient provides written informed consent
Exclusion Criteria
- Documented allergy to psoralens
- Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
- Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).
Data sourced from ClinicalTrials.gov (NCT02305732). 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.