Healthy SubjectsPhase 2NCT06697223

A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.

A Phase 2 study testing INTERCEPT Blood System for Platelets with LED Illuminator in people with Healthy Subjects, run by Cerus Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: INTERCEPT Blood System for Platelets with LED Illuminator
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 23 Jan 2025to 12 Jun 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18 years
Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
Meet FDA, AABB or institutional guidelines for allogeneic and plateletpheresis donor qualifications with the following exceptions:
o Deferrals due to travel, tattoos/piercings, male to male sexual contact as institutional policies allow
All routine infectious disease testing must be negative or non-reactive (during screening)
Subjects of childbearing potential must agree to use a medically acceptable (as per the Investigator) method of contraception throughout the study
Signed and dated informed consent form

Who cannot join

Clinically significant acute or chronic disease (as determined by the Investigator)
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))
Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
Treatment with any medication known to affect platelet viability
Pregnant or nursing females

Show all 11Show fewer

Received an investigational drug within the past 28 days or current participation in another clinical interventional study
Non study blood component donation throughout the study
Subjects with positive cocaine and/or amphetamine result from urine drug screen
Splenectomized subjects
History of known hypersensitivity to 51Chromium or 111Indium

Trial locations and contacts

2 sites in 1 country.

United States2 sites

American Red Cross Research Laboratory
Norfolk, Virginia, 23510
Bloodworks Northwest Research Institute
Seattle, Washington, 98102

Other trials in United States

About this study

Official title: A Randomized, Multi-center, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous Apheresis Platelet Components Suspended in 100% Plasma Treated With the INTERCEPT Blood System for Platelets With LED Illuminator Stored for 5 Days

The objective of this study is to assess the post-infusion recovery and survival of platelets in 100% Plasma treated with INTERCEPT Blood System for Platelets with LED Illuminator and stored for 5 days after apheresis collection. The post-infusion recovery and survival of autologous radiolabeled 5-day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to fresh autologous radiolabeled platelets (Control).

Read the 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 4.0 to 5.2 x10^11 platelets in 300 to 390 mL of plasma will be processed using the INTERCEPT Large Volume (LV) processing set. The INTERCEPT process will begin on either the day of collection (Day 0) or the day following collection (Day 1); illumination on the LED Illuminator must occur within 24 hours after the end of collection. Test platelet components will be stored for up to 5 days, after collection, in 100% plasma. In vitro platelet function will be evaluated on pre-treatment (Day 0/1), at the end of INTERCEPT treatment (Day 1/2), and at end of storage (Day 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 using Variant 1 BEST version 4.2.1 (Variant 1) method. Variant 1 method does not incorporate an initial soft spin in the presence of ACD A described in the BEST 4.2.1 method which results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. The method for collection and radiolabeling of the fresh Control platelets in Variant 1 of BEST 4.2.1 contains the same steps as published in the BEST 4.2.1 method (BEST).

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 5 days of storage for up to 24 evaluable subjects.

Test and Control platelets will be randomly radiolabeled with either 51Cr as sodium chromate (Na251CrO4) or 111In as Indium Oxine, depending upon randomization. Subjects will be randomized with equal probability to the radiolabeling sequences (111In/51Cr vs. 51Cr/111In) for Test INTERCEPT platelets/Control fresh platelets. 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 2 hours ±15 min post-infusion (Day 0), and 6 more samples will be drawn at 1 (within ±4 hours from time of infusion), 2, 3, 5±1, 7/8, and 11±1 days post-infusion (DPI)). The exact time of each sample draw will be recorded.

Subjects will be monitored for safety (adverse events including transfusion reactions) from the time of the apheresis procedure until 24 hours after the last DPI blood sample is drawn.

Conditions: Healthy Subjects
Being tested: INTERCEPT Blood System for Platelets with LED Illuminator
Keywords: INTERCEPT, Recovery, 5 Days, Survival, Radiolabel, Autologous, LED Illuminator, Apheresis Platelets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INTERCEPT Blood System for Platelets with LED IlluminatorDevice
Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) using the LED Illuminator and stored for 5 days at 20 to 24°C with continuous agitation.

Study groups in NCT06697223
Study group	Role	What they receive
Simultaneous administration of Test and Control platelets	Other	INTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, will be prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, will be simultaneously administered intravenously into the subject. Receives: Device: INTERCEPT Blood System for Platelets with LED Illuminator

What is being measured

The primary outcome is the main question the study is designed to answer.

Post Infusion Recovery of Test Platelets at End of 5 Day Storage
Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66*Control) in survival is greater than or equal to zero.
Measured: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Post Infusion Survival of Test Platelets at End of 5 Day Storage
Survival of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 * Control) in survival is greater than or equal to zero.
Measured: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets

Secondary outcomes (3)

Platelet Dose in Test Component
Percentage of Test components with ≥ 3.0×10^11 platelets
Measured: At the end of INTERCEPT treatment on Day 1 or Day 2
Platelet Yield Retention in Test Component
Percentage of Test components with ≥80% platelet yield retention
Measured: At the end of INTERCEPT treatment on Day 1 or Day 2
pH 22°C of Test Component
Percentage of Test components with pH 22°C ≥ 6.2
Measured: At end of 5 Day storage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 202512 Jun 2025

First posted20 Nov 2024
Study start23 Jan 2025
Primary completion2 Jun 2025
Study completion12 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06697223
Sponsor's protocol ID: CLI 00183
Status last verified: Jun 2026
First submitted: 18 Nov 2024
Last updated: 4 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multi-center, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous Apheresis Platelet Components Suspended in 100% Plasma Treated With the INTERCEPT Blood System for Platelets With LED Illuminator Stored for 5 Days
ClinicalTrials.gov ID: NCT06697223
Acronym / sponsor ID: CLI 00183
Conditions: Healthy Subjects
Keywords: INTERCEPT, Recovery, 5 Days, Survival, Radiolabel, Autologous, LED Illuminator, Apheresis Platelets
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Cerus CorporationIndustry (pharma, biotech, devices)
Study start: 23 Jan 2025 (actual)
Primary completion: 2 Jun 2025 (actual)
Study completion: 12 Jun 2025 (actual)
First posted: 20 Nov 2024 (actual)
Results: Posted 4 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Subjects will be monitored for safety (adverse events including transfusion reactions) from the time of the apheresis procedure until 24 hours after the last DPI blood sample is drawn.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Simultaneous administration of Test and Control platelets	Other	Device: INTERCEPT Blood System for Platelets with LED IlluminatorINTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, will be prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, will be simultaneously administered intravenously into the subject.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥18 years
Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.
Meet FDA, AABB or institutional guidelines for allogeneic and plateletpheresis donor qualifications with the following exceptions:
o Deferrals due to travel, tattoos/piercings, male to male sexual contact as institutional policies allow

Key exclusion criteria (11 listed)

Clinically significant acute or chronic disease (as determined by the Investigator)
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))
Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
Treatment with any medication known to affect platelet viability

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INTERCEPT Blood System for Platelets with LED IlluminatorApheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) using the LED Illuminator and stored for 5 days at 20 to 24°C with continuous agitation.	Device	Simultaneous administration of Test and Control platelets

Primary outcome

Post Infusion Recovery of Test Platelets at End of 5 Day Storage
Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66*Control) in survival is greater than or equal to zero.
Post Infusion Survival of Test Platelets at End of 5 Day Storage
Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
Survival of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 * Control) in survival is greater than or equal to zero.

3 secondary outcomes

Platelet Dose in Test Component
Time frame: At the end of INTERCEPT treatment on Day 1 or Day 2
Platelet Yield Retention in Test Component
Time frame: At the end of INTERCEPT treatment on Day 1 or Day 2
pH 22°C of Test Component
Time frame: At end of 5 Day storage

Results and safety

Results posted to the registry on 4 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simultaneous Administration of Test and Control Platelets	40	27

Primary outcome: Post Infusion Recovery of Test Platelets at End of 5 Day Storage

Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets. Mean (Standard Deviation). Unit: Percentage of infused platelets

Measure	Test Platelets n = 24	Control Platelets n = 24
Value	52.8 (11.4)	64.2 (11.7)

Test Platelets vs Control Platelets: Median Difference (Final Values): 10.5 (95% CI 7.7 to 13.3)

Population analysed: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.

Primary outcome: Post Infusion Survival of Test Platelets at End of 5 Day Storage

Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets. Mean (Standard Deviation). Unit: Hours

Measure	Test Platelets n = 24	Control Platelets n = 24
Value	157.4 (20.1)	207.3 (27.1)

Test Platelets vs Control Platelets: Median Difference (Final Values): 37.1 (95% CI 29.0 to 45.3)

Population analysed: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simultaneous Administration of Test and Control Platelets	0 of 29 (0%)	19 of 29 (65.5%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INTERCEPT Blood System for Platelets with LED Illuminator in people with Healthy Subjects, run by Cerus Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Infusion Recovery of Test Platelets at End of 5 Day Storage (time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06697223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.