INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections
RedeS
A Randomized, Double-Blind, Controlled, Parallel Group Study With the INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)
1 other identifier
interventional
692
3 countries
16
Brief Summary
To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in patients who require RBC transfusion support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
March 20, 2026
March 1, 2026
9.2 years
January 26, 2017
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adjusted hemoglobin increment
The difference between the pre-transfusion and post transfusion episode hemoglobin values divided by the total hemoglobin content transfused, averaged over one or more transfusion episodes in patients without active bleeding at baseline (active bleeding is defined as WHO Grade 3 or 4 bleeding)
15 minutes - 24 hours post transfusion
Adverse Events
Proportion of patients with any treatment-emergent adverse events (AEs) possibly, probably, or definitely related to study RBC transfusion through 28 days after the last study transfusion.
28 days
Treatment emergent antibodies
The proportion of patients with treatment emergent antibodies with confirmed specificity to IBS RBCs
75 days
Secondary Outcomes (8)
Adjusted hemoglobin consumption
211 Days
HbA clearance
211 days
Adverse Events
28 Days after last study transfusion
Transfusion reactions related to study RBCs (test or control)
28 Days after last study transfusion
RBC allo-antigens
28 days
- +3 more secondary outcomes
Study Arms (2)
INTERCEPT (Test)
EXPERIMENTALRed blood cell components treated with the INTERCEPT Blood System for Red Blood Cells ordered and administered to study patients by their treating physicians according to the local standards of care
Conventional (Control)
ACTIVE COMPARATORConventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care
Interventions
The pathogen reduction process begins with a unit of RBCs derived from whole blood that is separated according to local regulations and standard operating procedures at the Blood Centers. RBCs are suspended in AS-5 or SAG-M for non-US sites. Leukocyte-reduction of whole blood or RBCs will be performed per manufacturer's instructions. The INTERCEPT Blood System process is performed on a single unit of leukocyte-depleted RBC in AS-5.
Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care
Eligibility Criteria
You may qualify if:
- Age ≥ 4 years.
- Patients who require or are expected to require a transfusion of RBC component(s), including red cell exchange transfusion
- Signed and dated informed consent form.
- Female patients of child-bearing potential must:
- Have negative serum or urine pregnancy tests performed at the Screening visit within 30 days of randomization to rule out pregnancy, and
- Agree to use to use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner for the duration of study participation and an additional 28 days.
- For 28-day +6-month extension study in patients requiring repeated simple transfusions:
- A diagnosis of a bone marrow failure syndrome requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle cell anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.)
- For 28-day +6-month extension study in SCD patients requiring regular repeated RCE.
- Diagnosis of SCD, either HbSS, HbSC or HbSB0 thalassemia, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high-performance liquid chromatography (HPLC)
- Currently participating in an automated RCE transfusion program (for at least 3 months prior to enrollment) with 3-to-8 week intervals between RCE episodes
You may not qualify if:
- Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S- 303 treated RBC) as determined by INTERCEPT S 303 antibody screening panel prior to receiving the first study transfusion
- Pregnant or breast feeding.
- Presence of an RBC warm autoantibody with evidence of active hemolysis.
- Positive DAT as defined below:
- A polyspecific-DAT reaction strength \> 2+, or
- A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody.
- Patients presenting with or expected to have massive hemorrhage (≥10 RBC units within 24 hours) or expected to require massive transfusion protocols. Planned RCE does not apply.
- Patients who require neonatal transfusions and intrauterine transfusions.
- Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
- History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
- Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
- For SCD patients to be enrolled into the 28-day +6-month repeated RCE arm of the study:
- A history of acute chest syndrome in the last 6 months, or hyperhemolysis syndrome at any time.
- Clinical evidence of splenic hyperfunction or splenic enlargement: ≥18 cm in longitudinal diameter (diagnosed at the Investigator's discretion according to the data available, with ultrasound data being preferable).
- Currently receiving chemotherapy for treatment of cancer. Hydroxyurea for SCD is acceptable if subject has been on stable therapy for 3 months and no changes to dosage are planned.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Phoenix Children's Hospital (PCH)
Phoenix, Arizona, 85016, United States
Yale University
New Haven, Connecticut, 06520, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Grady Health System
Atlanta, Georgia, 30303, United States
CHOA (Children's Healthcare of Atlanta)
Atlanta, Georgia, 30316, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
C4TKs (Cure 4 The Kids)
Las Vegas, Nevada, 89135, United States
St Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77303, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Versiti
Wauwatosa, Wisconsin, 53226, United States
Menonita General Hospital
Aibonito, 00705, Puerto Rico
HIMA San Pablo Hospital
Caguas, 00725, Puerto Rico
San Juan Bautista School of Medicine Clinical Research Unit
Caguas, 00725, Puerto Rico
Ege University Hospital
Izmir, 35100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2017
First Posted
January 31, 2017
Study Start
May 11, 2017
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03