NCT04022889 is a Phase 2 clinical trial of INTERCEPT Treated Platelets in Healthy, sponsored by Cerus Corporation.

Who is sponsoring NCT04022889?

NCT04022889 is sponsored by Cerus Corporation.

What drugs are being tested in NCT04022889?

Interventions in NCT04022889: INTERCEPT Treated Platelets.

Is NCT04022889 still recruiting?

NCT04022889 is currently completed. Last updated 27 October 2022.

Are results published for NCT04022889?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-10-27 · How we verify

NCT04022889

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 27 October 2022

What this trial tests

Phase 2 trial testing INTERCEPT Treated Platelets in Healthy in 37 participants. Completed in 17 April 2021.

Timeline

5 November 2019

Primary endpoint
16 April 2021

17 April 2021

Quick facts

Lead sponsor	Cerus Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	37
Start date	5 November 2019
Primary completion	16 April 2021
Estimated completion	17 April 2021
Sites	2 locations across United States

Drugs / interventions tested

INTERCEPT Treated Platelets — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Cerus Corporation — full company profile →

Who can join

18 and older, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post Infusion Recovery of Test Platelets at End of Storage (Day 7) Primary · 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets

Recovery of Test platelets stored for 7 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.

Group	Value	95% CI
Stage 1 - Variant 1 Arm - TEST	39.5	± 10.3
Stage 1 - Variant 1 Arm - CONTROL	57.8	± 11.6
Stage 1 - BEST Arm- TEST	39.1	± 10.6
Stage 1 - BEST Arm - CONTROL	60.4	± 10.5
Stage 2 - TEST	37.6	± 8.4
Stage 2 - CONTROL	56.8	± 9.2

Post Infusion Survival of Test Platelets at End of Storage Primary · 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets

Survival of Test platelets stored for 7 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.

Group	Value	95% CI
Stage 1 - Variant 1 Arm- TEST	150.1	± 21.6
Stage 1 - Variant 1 Arm - CONTROL	208.9	± 15.8
Stage 1 - BEST Arm- TEST	143.2	± 33.6
Stage 1 - BEST Arm - CONTROL	202.9	± 24.4
Stage 2 - TEST	151.4	± 20.1
Stage 2 - CONTROL	209.6	± 13.9

Platelet Dose in Test Component Secondary · At the end of INTERCEPT treatment on Day 1 or Day 2

Percentage of Test components with ≥ 3.0×10\^11 platelets

Group	Value	95% CI
Stage 1 - Variant 1 Arm	12
Stage 1 - BEST Arm	13
Stage 2	22

Platelet Yield Retention Secondary · At the end of INTERCEPT treatment on Day 1 or Day 2

Percentage of Test components with ≥80% platelet yield retention

Group	Value	95% CI
Stage 1 - Variant 1 Arm	12
Stage 1 - BEST Arm	12
Stage 2	22

pH 22°C Secondary · At the end of storage on Day 7

Percentage of Test components with pH 22°C ≥ 6.2

Group	Value	95% CI
Stage 1 - Variant 1 Arm	13
Stage 1 - BEST Arm	13
Stage 2	23

Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume Secondary · At the end of storage on Day 7

Component volume was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	334	± 17
Stage 1 - BEST Arm	338	± 12
Stage 2	330	± 20

Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count Secondary · At the end of storage on Day 7

Platelet count was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	1116	± 185
Stage 1 - BEST Arm	1086	± 112
Stage 2	1133	± 176

Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose Secondary · At the end of storage on Day 7

Platelet dose was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	3.7	± 0.7
Stage 1 - BEST Arm	3.7	± 0.4
Stage 2	3.7	± 0.5

Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV Secondary · At the end of storage on Day 7

MPV was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	7.3	± 0.6
Stage 1 - BEST Arm	7.2	± 0.7
Stage 2	7.0	± 0.7

Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2 Secondary · At the end of storage on Day 7

pO2 was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	152.2	± 7.6
Stage 1 - BEST Arm	147.2	± 13.8
Stage 2	152.3	± 8.3

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2 Secondary · At the end of storage on Day 7

pO2 normalized for platelet count was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	43.5	± 10.6
Stage 1 - BEST Arm	42.4	± 7.3
Stage 2	42.5	± 8.4

Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2 Secondary · At the end of storage on Day 7

pCO2 was summarized descriptively for Stage 1 and Stage 2 Test components

Group	Value	95% CI
Stage 1 - Variant 1 Arm	26.5	± 3.1
Stage 1 - BEST Arm	27.4	± 2.3
Stage 2	26.3	± 2.8

Adverse events — posted to ClinicalTrials.gov

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), in both arms of Stage 1 (Variant 1 or BEST) and/or Stage 2. AEs were collected for the Safety Analysis Set, comprised of all subjects who initiated an apheresis collection.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage 1-Variant 1

Serious: 0/13 (0%)

Deaths: 0/13

Stage 1-BEST

Serious: 0/15 (0%)

Deaths: 0/15

Stage 2-Variant 1

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (21 terms — click to expand)

Reaction	System	Stage 1-Variant 1	Stage 1-BEST	Stage 2-Variant 1
Paraesthesia Oral	Gastrointestinal disorders	—	—	—
Injection site extravasation	General disorders	—	—	—
Paraesthesia	Nervous system disorders	—	—	—
Haematoma	Vascular disorders	—	—	—
Vessel puncture site bruise	General disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal distention	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Injection site haematoma	General disorders	—	—	—
Injection site pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Kidney Infection	Infections and infestations	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—
Arthraigia	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Presyncope	Nervous system disorders	—	—	—
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT04022889 adverse events section.

Sponsor's own description

The principle 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 autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to "fresh" autologous radiolabeled platelets (Control) according to FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol. A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration (BEST) or a variation of the BEST procedure (referred to as Variant 1) in Stage 1 of this study protocol. Cerus has demonstrated that the Variant 1 method, which does not incorporate an initial soft spin in the presence of ACD A, results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Cerus Corporation trials

Trials by the same sponsor.

NCT07152379 — Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Anti · Phase 2 · not yet recruiting
NCT07155031 — Biotin-Acridine Red Cell Exchange Kinetics · Phase 2 · withdrawn
NCT07015437 — A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS · Phase 2 · recruiting
NCT06697223 — A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood S · Phase 2 · completed
NCT03459287 — Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04022889 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cerus Corporation
Last refreshed: 27 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04022889.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing