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

Sponsor

Cerus Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT04022889

Collaborator

(none)

Enrollment

Locations

Arms

17.4

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The 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 radiolabeled 7, 6 or 5- day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to their "fresh" radiolabeled platelet (Control) according to FDA guidance for platelet testing (FDA 1999).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: INTERCEPT Treated Platelets	Phase 2

Detailed Description

The study population will consist of healthy subjects who meet the FDA, AABB, and site-specific research donor eligibility criteria for an apheresis platelet collection.

Apheresis platelets (single or double) will be collected in 100% plasma on the Trima Accel® Automated Blood Collection system. Each study apheresis collection will be processed using the INTERCEPT Blood System for platelets; apheresis platelets containing a platelet dose of 3.0 to 7.9 x10e11 platelets in 300 to 420 mL of plasma will be processed using the INTERCEPT Dual Storage (DS) processing set. The INTERCEPT process will begin on either the day of collection (Day 0) or the day following collection (Day 1); illumination must occur within 24 hours after the end of collection. Test platelet components will be stored for up to 7 days, after collection, in 100% plasma. In vitro platelet function will be evaluated on Days 0/1 (pre-treatment) and at end of storage (Day 7, 6 and/or 5).

At the end of storage, an aliquot of Test platelets will be aseptically removed from each subject's INTERCEPT platelet storage container and prepared for radiolabeling. The in vitro quality of the Test platelet sample used for radiolabeling will be assessed prior to and following the pre-radiolabeling platelet sample preparations.

The recovery and survival for Test platelets will be compared against the fresh platelet Control. Recovery and survival of INTERCEPT platelets will be assessed after Day 7, 6 or 5 days of storage for up to 24 evaluable subjects.

Test and Control will be randomly radiolabeled with either 51Cr as sodium radiochromate (Na251CrO4) or 111In as indium oxine, depending upon randomization period and assignment. Subjects will be randomized with equal probability to the radiolabeling sequences (111In/51Cr vs. 51Cr/111In) for Test/Control. After radiolabeling, the autologous Control and Test platelet samples will be simultaneously infused into the subject.

Blood samples will be drawn immediately before infusion and for radioactivity measurements at 1 hour ± 15 min and 2 hours ± 15 min post-infusion (Day 0), and 6 more samples will be drawn at 1, 2, 3, 4 (or 5 or 6), 7 (or 8), and 11±1 days post-infusion (DPI), at approximately the same time of day as the radiolabeled platelet infusion was administered (±4 hours).

Subjects will be monitored for safety (adverse events) from the first apheresis procedure until after the last DPI blood sample is drawn.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Randomized, Multi-center, Multi-Stage, Controlled, 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

Actual Study Start Date :

Nov 5, 2019

Actual Primary Completion Date :

Apr 16, 2021

Actual Study Completion Date :

Apr 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stage 1 Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled using either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control.	Device: INTERCEPT Treated Platelets Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7, 6 or 5 days at 20°C-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets will be simultaneously administered intravenously into the subject.
Experimental: Stage 2 Stage 2 is a single arm study in which all Test platelets will be prepared for radiolabeling using the Variant 1 methodology. The recovery and survival for Test platelets will be compared against the fresh platelet Control. Recovery and survival of INTERCEPT platelets will be assessed after Day 7, 6 or 5 days of storage for up to 24 evaluable subjects. The storage duration of the Test platelet components will be determined by Cerus based on the outcome of Stage 1.	Device: INTERCEPT Treated Platelets Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7, 6 or 5 days at 20°C-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets will be simultaneously administered intravenously into the subject.

Arm

Intervention/Treatment

Experimental: Stage 1

Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled using either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control.

Device: INTERCEPT Treated Platelets

Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7, 6 or 5 days at 20°C-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets will be simultaneously administered intravenously into the subject.

Experimental: Stage 2

Stage 2 is a single arm study in which all Test platelets will be prepared for radiolabeling using the Variant 1 methodology. The recovery and survival for Test platelets will be compared against the fresh platelet Control. Recovery and survival of INTERCEPT platelets will be assessed after Day 7, 6 or 5 days of storage for up to 24 evaluable subjects. The storage duration of the Test platelet components will be determined by Cerus based on the outcome of Stage 1.

Device: INTERCEPT Treated Platelets

Outcome Measures

Primary Outcome Measures

Post infusion recovery of Test platelets at end of storage (Day 7, 6 or 5) [7, 6, or 5 Day]
Post infusion survival of Test platelets at end of storage [7, 6, or 5 Day]
Adverse events [start of the apheresis collection through 11 days (±1) following the last radiolabeled infusion.]

Secondary Outcome Measures

Platelet dose ≥3.0×10e11 [At the end of INTERCEPT treatment on Day 1 or Day 2]
Physical Platelet recovery ≥80% [At the end of INTERCEPT treatment on Day 1 or Day 2]
pH 22°C (≥6.2) [At end of storage 7, 6, or 5 Day]

Other Outcome Measures

Physical Platelet recovery (≥80%) [At the end of storage 7, 6, or 5 Day as applicable]
pH 22°C (≥6.2) [At the end of storage 7, 6, or 5 Day as applicable]
RBC count [At the end of storage 7, 6, or 5 Day as applicable]
WBC count [At the end of storage 7, 6, or 5 Day as applicable]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥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 150×10e9 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:

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.