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 | Completed Phase 2

• 1 other identifier: CLI 00099
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

INTERCEPT; platelet; pathogen inactivation; platelet components stored; therapeutic efficacy

Outcome Measures

Primary Outcomes (4)

• Post infusion recovery ratio of Test platelets at Day 7 compared to fresh platelets

  Day 7

• Post infusion lifespan ratio of Test platelets at Day 7 compared to fresh platelets

  Day 7

• In vitro pH at Day 7

  Day 7

• Adverse events, vital signs, hematological profile and serum chemistry profile

  Days 0 to 17

Secondary Outcomes (4)

• Product parameters

  Day 7

• Biochemical assessments

  Day 7

• Functional assessments

  Day 7

• Bacterial contamination

  Day 7

Study Arms (2)

Amicus platelet components

EXPERIMENTAL

The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 1, apheresis platelets will be collected using the Amicus separator and stored for 7 days in 35% Plasma and 65% InterSol

Biological: INTERCEPT treated platelets

Trima platelet components

EXPERIMENTAL

The two stages of this pilot study consist of the following: single or double dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fresh platelets, radiolabeling, infusion of fresh and stored INTERCEPT treated radiolabeled autologous platelets, and collection of blood samples for assessment of platelet recovery and survival (lifespan). In Stage 2, apheresis platelets will be collected using the Trima separator and stored for 7 days in 100% plasma.

Biological: INTERCEPT treated platelets

Interventions

INTERCEPT treated platelets BIOLOGICAL

Amicus platelet components; Trima platelet components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-minimum of 18 years, of either gender
• Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
• Meet FDA and AABB guidelines for autologous apheresis platelet donation
• Complete blood count (CBC) and serum chemistry values within normal limits
• Pre-donation platelet count of more than 150×109 platelets/L
• Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV
• Male and female 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

You may not qualify if:

• Clinically significant acute or chronic disease (as determined by the Investigator)
• Pregnant or nursing females
• Male or female subjects of childbearing potential not using effective contraception
• Disease states or conditions that preclude blood donation or 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)
• Smokers using \>10 cigarettes/day for the last 3 months
• Splenectomized subjects
• Prior exposure to amotosalen
• History of known hypersensitivity to indium or chromium
• Participation in another clinical study currently or within the past 28 days

Sponsors & Collaborators

• Cerus Corporation: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 8, 2017

Record last verified: 2017-11