Status:
RECRUITING
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Lead Sponsor:
Cerus Corporation
Conditions:
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood...
Detailed Description
Study Design This trial is designed as a prospective, randomized, controlled, single-blind (subject blinded), 2-arm parallel study to evaluate 24-hour post-infusion recovery and lifespan of 35-day-ol...
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- 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 WB donation, including viral marker testing, with the following exceptions:
- Meeting allogeneic deferral criteria due to travel, tattoos/piercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.
- Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.
- Signed and dated informed consent form
Exclusion Criteria:
- History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease
- History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)
- Positive DAT or IAT at study entry
- Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days
- Treatment with any medication known to affect RBC viability
- Pregnant or nursing females
- Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days
- Less than three months from receiving an infusion of a radiolabeled blood component.
- Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.
- Non study blood component donation throughout the study
- Preexisting antibody specific to INTERCEPT RBCs
- History of known hypersensitivity to chromium or technetium
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07015437
Start Date
September 19 2025
End Date
October 15 2026
Last Update
October 15 2025
Active Locations (2)
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1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
2
American Red Cross Research Laboratory
Norfolk, Virginia, United States, 23510