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A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Treated 7-Day Stored Apheresis Platelet Components in 35% Plasma and 65% InterSol and 7-Day Stored Apheresis Platelet Components in 100% Plasma

NCT02310412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-11-08

No results posted yet for this study

Summary

The objective of this study is to test the hypothesis that INTERCEPT platelet components stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of 7-day old INTERCEPT platelet components stored in 35% plasma and 65% InterSol or stored in 100% plasma, will be measured in comparison to "fresh" radiolabeled platelets according to FDA guidance for platelet testing (FDA 1999).

Conditions

  • Healthy

Interventions

BIOLOGICAL

INTERCEPT treated platelets

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-05-31
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02310412 on ClinicalTrials.gov