Status:
NOT_YET_RECRUITING
Biotin-Acridine Red Cell Exchange Kinetics
Lead Sponsor:
Cerus Corporation
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter ref...
Detailed Description
This trial is designed as a prospective, Phase 2, non-randomized, open-label, single arm, single center study in at least five (5) patients with sickle cell disease (SCD) undergoing red cell exchange ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- homozygous sickle cell disease (HbSS) or Hemoglobin S-β-thalassemia (HbSβ0) SCD
- Receiving RCE for ≥3 months prior to enrollment and scheduled to undergo at least 4 sequential RCE episodes during the period of enrollment in the study
Exclusion
- Anticipated cessation of RBC transfusion therapy in the next ≤2 months
- Planned stem cell transplant or gene therapy in the next 6 months
- Delayed hemolytic transfusion reaction in the past 3 months
- History of hyperhemolysis syndrome at any time
- Consuming high-dose biotin or raw egg supplements
- Current pregnancy
- Antibody specific to INTERCEPT RBCs or biotinylated red blood cells (BioRBCs) at baseline
- Patients with RBC alloantibodies that make it difficult to provide antigen matched blood.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07155031
Start Date
October 15 2025
End Date
December 15 2026
Last Update
September 10 2025
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