CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
INTERCEPT Plateletsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02305732
NCT02305732N/ACompleted
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A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

Cerus Corporation·observational·Posted Dec 3, 2014·Updated Oct 30, 2018

In Brief

An observational study evaluating INTERCEPT Platelets for Chikungunya Virus and Dengue Virus. Completed, enrolled 90 participants across 8 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChikungunya Virus, Dengue Virus
CountriesPuerto Rico
CollaboratorsAmerican National Red Cross

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartMar 1, 2015
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.6 years ago

Interventions

INTERCEPT Plateletsbiological

INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.