AnemiaPhase 3RedeSNCT03037164
INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections
A Phase 3 study testing INTERCEPT Blood System for Red Blood Cells in people with Anemia, run by Cerus Corporation at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- INTERCEPT Blood System for Red Blood Cells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 10 May 2017to 6 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within 28 days prior to randomization. Prior receipt of conventional blood products tested with an investigational NAT test is not considered ground for exclusion.
- 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.
- Subject is in active treatment with renal dialysis.
- Any subject for whom a substantial change in the number of RBC components transfused is anticipated due to anticipated splenectomy, bone marrow transplant, surgery or other change in clinical status.
- Subject with known G6PD deficiency or requiring treatment with medications that are known to adversely affect RBC viability or bone marrow function.
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States12 sites
Grady Health System
Atlanta, Georgia, 30303
CHOA (Children's Healthcare of Atlanta)
Atlanta, Georgia, 30316
University of Maryland School of Medicine
Baltimore, Maryland, 21201
UT Southwestern Medical Center
Dallas, Texas, 75390
Baylor St. Luke's Medical Center
Houston, Texas, 77303
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
C4TKs (Cure 4 The Kids)
Las Vegas, Nevada, 89135
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Yale University
New Haven, Connecticut, 06520
Phoenix Children's Hospital (PCH)
Phoenix, Arizona, 85016
Virginia Commonwealth University
Richmond, Virginia, 23298
Versiti
Wauwatosa, Wisconsin, 53226
Puerto Rico3 sites
Menonita General Hospital
Aibonito, 00705
HIMA San Pablo Hospital
Caguas, 00725
San Juan Bautista School of Medicine Clinical Research Unit
Caguas, 00725
About this study
Official title: 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)
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.
Read the detailed description
Patients will be approached, consented, screened for eligibility and randomized to receive either Test or Control RBCs in one of the three arms at the beginning of the study:
- Bleeding or non-bleeding patients at baseline may be enrolled into the acute 28-day transfusion period.
- Non-bleeding patients at baseline with chronic anemia requiring repeated simple transfusion may be enrolled into the 28-day +6-month extension period.
- SCD on a regular repeated RCE program at baseline may be enrolled into 28-day +6-month extension period to receive a total of 3 consecutive RCE procedures.
Eligible patients will be randomized and transfused with study RBCs (Test or Control with 1:1 ratio) according to local practices for up to 28 days of transfusion support. Following the 28-day acute transfusion support period, patients will be transfused with conventional RBC components as indicated by their treating physician unless they were enrolled at baseline in the optional 6-month extension period.
Non-bleeding patients at baseline requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.) will be eligible to participate in an extension option for up to 6 months or up to 10 transfusion episodes, whichever occurs first, to evaluate patients requiring repeated transfusion for chronic anemia.
In addition, SCD patients on a regular RCE program at 2 or more clinical sites may be enrolled at baseline into the 6-month extension period to receive up to a total of 3 consecutive RCE procedures.
Screening/Recruitment
All potentially eligible patients at participating institutions will be approached for study consent. Subjects <18 years of age will require subject assent and parental consent. For subjects eligible for enrollment into the 6-month extension period option, consent/assent for the extension period should be obtained at initial enrollment.
Patients who consent to the study will be assigned a study ID number and undergo screening. Screening data collection and procedures will include:
Demographics (age, sex), vital signs, height, weight, indication for anticipated transfusion, type of scheduled surgery (if applicable), medical and surgical history, transfusion history, physical examination, comorbid conditions, concomitant medications, hematology panel, blood type and Rh, Indirect Antiglobulin Test (IAT), blood chemistry, coagulation panel, Direct Antiglobulin Test (DAT), immune reactivity to IBS RBCs (if available), pregnancy test (when applicable). Once all screening assessments are completed and eligibility is confirmed, the subject may be randomized.
For SCD patients on a regular RCE program, if available in the medical record, the pre- and post- RCE total Hemoglobin, HbA, HbS and HbF concentrations should be recorded for up to 6 months prior to the first study transfusion.
If results from the Screening assessments are available in the medical record within 30 days prior to randomization, those data may serve as the screening data and the assessments do not need to be repeated unless the subject has an RBC transfusion in the 30-day period.
If an RBC transfusion occurs after determined eligibility but prior to randomization, the subject may be randomized and those Screening assessments should be repeated prior to the first study transfusion.
A pregnancy test (when applicable) must be performed at the Screening visit within 30 days of randomization.
Randomization and Blinding
Potential patients will be consented and begin screening in the study in order to determine eligibility for inclusion in one of the three study arms. An Interactive Web Response System (IWRS) will be used for electronic randomization of eligible patients to receive Test or Control RBCs.
Randomization will be at a 1:1 ratio of Test: Control and stratified by site, baseline bleeding status [indication for RBC transfusion due to active bleeding or for anemia without active bleeding], patients' participation in the optional extension period (yes/no) and patients' need for RCE. Anticipated surgical bleeding and planned blood loss/replacement through RCE at baseline should be included as active bleeding (Grade ≥3) by definition. Randomized patients who do not receive any study RBC transfusions through 28 days after randomization will be withdrawn from the study and replaced. Additional data will not be collected for these patients. These subjects may be reassessed for eligibility and re-enrollment after withdrawal.
At the end of screening, the patient's eligibility status will be entered into the electronic data capture system (EDC). If eligible, the patient will be randomized. Only appropriate blood bank staff will be able to access the treatment arm assignment. Study RBC unit labels will be indistinguishable for Test and Control products. Medical staff, and others caring for participating patients, as well as the sponsor (and delegates) will be blinded to treatment assignment. Unblinded delegates will monitor the production of the RBC components at designated blood centers.
Treatment
Repeated Simple Transfusion Arm In the initial acute transfusion period, randomized patients will be transfused with Test or Control RBC components for up to 28 days. If the patient is entered into the optional extension period, randomized patients will be transfused with Test or Control RBC components for an additional 6 months, or up to 10 transfusion episodes, whichever occurs first. Subjects participating in optional extended study will continue to receive the same study RBCs (Test or Control) as in their initial 28-day study period for up to 10 transfusion episodes. Patients will be transfused with conventional RBC components as indicated by their treating physician once the 10 transfusion episodes or 6 months has been completed.
An RBC transfusion episode is defined to include consecutive RBC units transfused until the next post-transfusion Hb determination with ≤12 hours between transfusions (from the end of a prior component transfused to the start of a subsequent component transfused).
RCE Arm SCD patients on a regular RCE program enrolled into the 6-month extension period will receive 3 consecutive RCE procedures with study RBC with an interval of 3-8 weeks between RCE procedures, as determined by their physician.
A confirmed negative immune reaction to IBS RBC is required prior to the first study transfusion/RCE and at every time point a Type and Screen (IAT) is performed for a patient within the 28-day acute transfusion period or during the extension period. Compatibility for RBC antigens will be confirmed using site's SOPs prior to transfusion of study RBCs. In case of confirmed physiologically active antibodies to IBS RBC or any presumed or documented antibodies to IBS RBC that preclude further transfusion with study RBCs, patients will be withdrawn from the study treatment and supported with conventional RBC components and followed for safety. Patients with antibodies to IBS RBC will be investigated for evidence of hemolysis and continue with all planned visits and safety monitoring.
Study Assessments: Monitoring and Follow-up
The acute transfusion support period will comprise 28 days from the day of the first study transfusion (Day 1) through Day 28, or death. For subjects enrolled in the optional extension period, they will receive transfusion support for an additional 6-months.
During these periods, patients enrolled into the 6-month repeated simple transfusion arm will receive as many study RBCs as deemed appropriate by the treating physician for up to 10 transfusion episodes. Patients enrolled into the 6-month RCE arm will receive 3 consecutive RCE. All adverse events (AE), serious AE (SAE), transfusion reactions (TR) and unanticipated adverse device effects (UADE) will be collected starting from the initiation of the first study transfusion through exactly 28 days after the last study transfusion or death, whichever occurs first. The Investigators will assess each AE/SAE/TR/UADE for relation to the transfused study RBCs. TR will be classified by the definitions in the CDC NHSN Hemovigilance Module Surveillance Protocol and will be captured in the eCRF and in the CDC NHSN Biovigilance Component/Hemovigilance Module, if in routine use by the site (www.cdc.gov/nhsn).
Most proximate vital signs in the medical record will be collected prior to and following each study transfusion. The subject's hemoglobin value will be collected from the medical record, or if not available, a study sample will be submitted for testing, prior to and following each study transfusion episode/RCE within 15 minutes to 24 hours after the end of the transfusion episode and before the next RBC transfusion.
Relevant concomitant medications taken during the study and blood products transfused will be recorded with indication, total daily dose, and dates of drug administration.
During the acute transfusion period, patients will undergo the following assessments prior to each transfusion episode: vital signs, AEs, TRs, SAEs and UADEs, comorbid conditions, blood samples for safety labs (hematology panel, blood chemistry panel), IAT and immune reactivity to IBS RBCs. Samples may be used for additional in vitro research tests as required to confirm transfusion-transmitted infections.
An immune reactivity to IBS RBCs test will be performed and resulted each time an IAT is performed within the 28-day acute and 6-month extension transfusion support period.
RCE Arm
The following parameters should be assessed before and 15 mins to 4 hours after each RCE procedure:
- Hematology panel
- Reticulocytes
- % of HbS, HbA, and HbF
- Coagulation panel
- Plasma frozen sample for determination of S-300 and GSH concentrations
Day 14 (±7 days) after each RCE procedure for SCD patients undergoing regular RCE:
- Hematology panel
- Reticulocytes
- % of HbS, HbA, and HbF
Follow-Up Period for all transfused patients For the purposes of the Day 28 (± 7 days) and Day 75 (± 15 days) follow-up visits, Day 1 of the follow-up period is the day after the last study transfusion, either in the initial 28-day acute transfusion period or, if the subject is entered, in the optional extension period.
Day 28 (± 7 days) after the last study transfusion or before first post-study RCE with conventional RBCs in patients on a regular RCE program
Vital signs will be collected, and blood samples will be collected for:
- Hematology panel
- Blood chemistry panel
- Coagulation panel
- DAT and IAT
- Immune reactivity test for IBS RBC
- In addition for SCD patients undergoing regular RCE:
- Reticulocytes
- % of HbS, HbA, and HbF
- Plasma frozen sample for determination of S-300 and GSH concentrations.
All AEs, SAEs, TRs and UADEs will be reviewed and recorded for the period from the first study transfusion through exactly 28 days after the last study transfusion.
End of Study Visit Day 75 (±15 days) after the last study transfusion) for all transfused patients
Blood samples will be collected for:
- DAT
- Immune reactivity test for IBS RBC
- Conditions
- Anemia
- Being tested
- INTERCEPT Blood System for Red Blood Cells, Conventional (Control)
- Keywords
- INTERCEPT, Red Blood Cells, RBC, Pathogen Inactivation, Zika, Cerus, Pathogen Reduction
- Medical subject headings
- Anemia, Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCEPT Blood System for Red Blood CellsDevice
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 (Control)Device
Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care
| Study group | Role | What they receive |
|---|---|---|
| INTERCEPT (Test) | Experimental | Red 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 Receives: Device: INTERCEPT Blood System for Red Blood Cells |
| Conventional (Control) | Active comparator | Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care Receives: Device: Conventional (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 28 days
Treatment emergent antibodies
The proportion of patients with treatment emergent antibodies with confirmed specificity to IBS RBCs
Measured: 75 days
Secondary outcomes (8)
Adjusted hemoglobin consumption
Defined as total hemoglobin mass transfused in grams divided by body weight in kg at baseline and duration of the study transfusion period in days (g/kg/day), in patients without active bleeding at baseline.
Measured: 211 Days
HbA clearance
HbA clearance in patients with SCD undergoing regular repeated RCE
Measured: 211 days
Adverse Events
Treatment-emergent AEs
Measured: 28 Days after last study transfusion
Transfusion reactions related to study RBCs (test or control)
Defined by the CDC National Healthcare Safety Network [NHSN] Hemovigilance Module protocol
Measured: 28 Days after last study transfusion
RBC allo-antigens
Treatment-emergent immunization to RBC allo-antigens
Measured: 28 days
Mortality
All-cause mortality
Measured: 28 Days after last study transfusion
Adverse Events of Special Interest (AESI)
Proportion of subjects with adverse events of special interest (AESI) through 28 days after the last study transfusion.
Measured: 28 Days after last study RCE
S-300 and GSH plasma levels
S-300 and Glutathione (GSH) plasma levels
Measured: 15 minutes to 4 hrs after RCE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start10 May 2017
- Primary completion29 Apr 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037164
- Sponsor's protocol ID
- CLI 00126
- Other IDs
- HHSO100201600009C
- Acronym
- RedeS
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2017
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ayala EFC, Colon LV, Aydinok Y, Arboleda-Osorio B, Bracey A, Fasano R, Yee M, Sarode R, Zubair AC, Nizzi F, Shah S, Snyder EL, Treml A, Zheng Y, Takemoto C, Green J, Jackson B, Pitman JP, Gniadek TJ, Liu K, Bentow S, Corash L, Mufti N, Benjamin RJ. A randomized, double-blind, controlled, parallel group study with amustaline/glutathione pathogen reduced red blood cells in regions at potential risk for Zika virus transfusion-transmitted infections (RedeS Study)-protocol for a phase 3 clinical trial. Trials. 2026 May 26;27(1):507. doi: 10.1186/s13063-026-09808-y.
PubMed 42186075
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03037164
- Acronym / sponsor ID
- RedeS / CLI 00126
- Conditions
- Anemia
- Keywords
- INTERCEPT, Red Blood Cells, RBC, Pathogen Inactivation, Zika, Cerus, Pathogen Reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be approached, consented, screened for eligibility and randomized to receive either Test or Control RBCs in one of the three arms at the beginning of the study:
- Bleeding or non-bleeding patients at baseline may be enrolled into the acute 28-day transfusion period.
- Non-bleeding patients at baseline with chronic anemia requiring repeated simple transfusion may be enrolled into the 28-day +6-month extension period.
- SCD on a regular repeated RCE program at baseline may be enrolled into 28-day +6-month extension period to receive a total of 3 consecutive RCE procedures.
Eligible patients will be randomized and transfused with study RBCs (Test or Control with 1:1 ratio) according to local practices for up to 28 days of transfusion support. Following the 28-day acute transfusion support period, patients will be transfused with conventional RBC components as indicated by their treating physician unless they were enrolled at baseline in the optional 6-month extension period.
Non-bleeding patients at baseline requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.) will be eligible to participate in an extension option for up to 6 months or up to 10 transfusion episodes, whichever occurs first, to evaluate patients requiring repeated transfusion for chronic anemia.
In addition, SCD patients on a regular RCE program at 2 or more clinical sites may be enrolled at baseline into the 6-month extension period to receive up to a total of 3 consecutive RCE procedures.
Screening/Recruitment
All potentially eligible patients at participating institutions will be approached for study consent. Subjects <18 years of age will require subject assent and parental consent. For subjects eligible for enrollment into the 6-month extension period option, consent/assent for the extension period should be obtained at initial enrollment.
Patients who consent to the study will be assigned a study ID number and undergo screening. Screening data collection and procedures will include:
Demographics (age, sex), vital signs, height, weight, indication for anticipated transfusion, type of scheduled surgery (if applicable), medical and surgical history, transfusion history, physical examination, comorbid conditions, concomitant medications, hematology panel, blood type and Rh, Indirect Antiglobulin Test (IAT), blood chemistry, coagulation panel, Direct Antiglobulin Test (DAT), immune reactivity to IBS RBCs (if available), pregnancy test (when applicable). Once all screening assessments are completed and eligibility is confirmed, the subject may be randomized.
For SCD patients on a regular RCE program, if available in the medical record, the pre- and post- RCE total Hemoglobin, HbA, HbS and HbF concentrations should be recorded for up to 6 months prior to the first study transfusion.
If results from the Screening assessments are available in the medical record within 30 days prior to randomization, those data may serve as the screening data and the assessments do not need to be repeated unless the subject has an RBC transfusion in the 30-day period.
If an RBC transfusion occurs after determined eligibility but prior to randomization, the subject may be randomized and those Screening assessments should be repeated prior to the first study transfusion.
A pregnancy test (when applicable) must be performed at the Screening visit within 30 days of randomization.
Randomization and Blinding
Potential patients will be consented and begin screening in the study in order to determine eligibility for inclusion in one of the three study arms. An Interactive Web Response System (IWRS) will be used for electronic randomization of eligible patients to receive Test or Control RBCs.
Randomization will be at a 1:1 ratio of Test: Control and stratified by site, baseline bleeding status [indication for RBC transfusion due to active bleeding or for anemia without active bleeding], patients' participation in the optional extension period (yes/no) and patients' need for RCE. Anticipated surgical bleeding and planned blood loss/replacement through RCE at baseline should be included as active bleeding (Grade ≥3) by definition. Randomized patients who do not receive any study RBC transfusions through 28 days after randomization will be withdrawn from the study and replaced. Additional data will not be collected for these patients. These subjects may be reassessed for eligibility and re-enrollment after withdrawal.
At the end of screening, the patient's eligibility status will be entered into the electronic data capture system (EDC). If eligible, the patient will be randomized. Only appropriate blood bank staff will be able to access the treatment arm assignment. Study RBC unit labels will be indistinguishable for Test and Control products. Medical staff, and others caring for participating patients, as well as the sponsor (and delegates) will be blinded to treatment assignment. Unblinded delegates will monitor the production of the RBC components at designated blood centers.
Treatment
Repeated Simple Transfusion Arm In the initial acute transfusion period, randomized patients will be transfused with Test or Control RBC components for up to 28 days. If the patient is entered into the optional extension period, randomized patients will be transfused with Test or Control RBC components for an additional 6 months, or up to 10 transfusion episodes, whichever occurs first. Subjects participating in optional extended study will continue to receive the same study RBCs (Test or Control) as in their initial 28-day study period for up to 10 transfusion episodes. Patients will be transfused with conventional RBC components as indicated by their treating physician once the 10 transfusion episodes or 6 months has been completed.
An RBC transfusion episode is defined to include consecutive RBC units transfused until the next post-transfusion Hb determination with ≤12 hours between transfusions (from the end of a prior component transfused to the start of a subsequent component transfused).
RCE Arm SCD patients on a regular RCE program enrolled into the 6-month extension period will receive 3 consecutive RCE procedures with study RBC with an interval of 3-8 weeks between RCE procedures, as determined by their physician.
A confirmed negative immune reaction to IBS RBC is required prior to the first study transfusion/RCE and at every time point a Type and Screen (IAT) is performed for a patient within the 28-day acute transfusion period or during the extension period. Compatibility for RBC antigens will be confirmed using site's SOPs prior to transfusion of study RBCs. In case of confirmed physiologically active antibodies to IBS RBC or any presumed or documented antibodies to IBS RBC that preclude further transfusion with study RBCs, patients will be withdrawn from the study treatment and supported with conventional RBC components and followed for safety. Patients with antibodies to IBS RBC will be investigated for evidence of hemolysis and continue with all planned visits and safety monitoring.
Study Assessments: Monitoring and Follow-up
The acute transfusion support period will comprise 28 days from the day of the first study transfusion (Day 1) through Day 28, or death. For subjects enrolled in the optional extension period, they will receive transfusion support for an additional 6-months.
During these periods, patients enrolled into the 6-month repeated simple transfusion arm will receive as many study RBCs as deemed appropriate by the treating physician for up to 10 transfusion episodes. Patients enrolled into the 6-month RCE arm will receive 3 consecutive RCE. All adverse events (AE), serious AE (SAE), transfusion reactions (TR) and unanticipated adverse device effects (UADE) will be collected starting from the initiation of the first study transfusion through exactly 28 days after the last study transfusion or death, whichever occurs first. The Investigators will assess each AE/SAE/TR/UADE for relation to the transfused study RBCs. TR will be classified by the definitions in the CDC NHSN Hemovigilance Module Surveillance Protocol and will be captured in the eCRF and in the CDC NHSN Biovigilance Component/Hemovigilance Module, if in routine use by the site (www.cdc.gov/nhsn).
Most proximate vital signs in the medical record will be collected prior to and following each study transfusion. The subject's hemoglobin value will be collected from the medical record, or if not available, a study sample will be submitted for testing, prior to and following each study transfusion episode/RCE within 15 minutes to 24 hours after the end of the transfusion episode and before the next RBC transfusion.
Relevant concomitant medications taken during the study and blood products transfused will be recorded with indication, total daily dose, and dates of drug administration.
During the acute transfusion period, patients will undergo the following assessments prior to each transfusion episode: vital signs, AEs, TRs, SAEs and UADEs, comorbid conditions, blood samples for safety labs (hematology panel, blood chemistry panel), IAT and immune reactivity to IBS RBCs. Samples may be used for additional in vitro research tests as required to confirm transfusion-transmitted infections.
An immune reactivity to IBS RBCs test will be performed and resulted each time an IAT is performed within the 28-day acute and 6-month extension transfusion support period.
RCE Arm
The following parameters should be assessed before and 15 mins to 4 hours after each RCE procedure:
- Hematology panel
- Reticulocytes
- % of HbS, HbA, and HbF
- Coagulation panel
- Plasma frozen sample for determination of S-300 and GSH concentrations
Day 14 (±7 days) after each RCE procedure for SCD patients undergoing regular RCE:
- Hematology panel
- Reticulocytes
- % of HbS, HbA, and HbF
Follow-Up Period for all transfused patients For the purposes of the Day 28 (± 7 days) and Day 75 (± 15 days) follow-up visits, Day 1 of the follow-up period is the day after the last study transfusion, either in the initial 28-day acute transfusion period or, if the subject is entered, in the optional extension period.
Day 28 (± 7 days) after the last study transfusion or before first post-study RCE with conventional RBCs in patients on a regular RCE program
Vital signs will be collected, and blood samples will be collected for:
- Hematology panel
- Blood chemistry panel
- Coagulation panel
- DAT and IAT
- Immune reactivity test for IBS RBC
- In addition for SCD patients undergoing regular RCE:
- Reticulocytes
- % of HbS, HbA, and HbF
- Plasma frozen sample for determination of S-300 and GSH concentrations.
All AEs, SAEs, TRs and UADEs will be reviewed and recorded for the period from the first study transfusion through exactly 28 days after the last study transfusion.
End of Study Visit Day 75 (±15 days) after the last study transfusion) for all transfused patients
Blood samples will be collected for:
- DAT
- Immune reactivity test for IBS RBC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERCEPT (Test) | Experimental | Device: INTERCEPT Blood System for Red Blood CellsRed 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 comparator | Device: Conventional (Control)Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.)
Key exclusion criteria (19 listed)
- 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:
- Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within 28 days prior to randomization. Prior receipt of conventional blood products tested with an investigational NAT test is not considered ground for exclusion.
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 Red Blood CellsThe 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. | Device | INTERCEPT (Test) |
| Conventional (Control)Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care | Device | Conventional (Control) |
Primary outcome
Adjusted hemoglobin increment
Time frame: 15 minutes - 24 hours post transfusion
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)
Adverse Events
Time frame: 28 days
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.
Treatment emergent antibodies
Time frame: 75 days
The proportion of patients with treatment emergent antibodies with confirmed specificity to IBS RBCs
8 secondary outcomes
Adjusted hemoglobin consumption
Time frame: 211 Days
HbA clearance
Time frame: 211 days
Adverse Events
Time frame: 28 Days after last study transfusion
Transfusion reactions related to study RBCs (test or control)
Time frame: 28 Days after last study transfusion
RBC allo-antigens
Time frame: 28 days
Mortality
Time frame: 28 Days after last study transfusion
Adverse Events of Special Interest (AESI)
Time frame: 28 Days after last study RCE
S-300 and GSH plasma levels
Time frame: 15 minutes to 4 hrs after RCE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Derived from this study: PubMed 42186075Ayala EFC, Colon LV, Aydinok Y, Arboleda-Osorio B, Bracey A, Fasano R, Yee M, Sarode R, Zubair AC, Nizzi F, Shah S, Snyder EL, Treml A, Zheng Y, Takemoto C, Green J, Jackson B, Pitman JP, Gniadek TJ, Liu K, Bentow S, Corash L, Mufti N, Benjamin RJ. A randomized, double-blind, controlled, parallel group study with amustaline/glutathione pathogen reduced red blood cells in regions at potential risk for Zika virus transfusion-transmitted infections (RedeS Study)-protocol for a phase 3 clinical trial. Trials. 2026 May 26;27(1):507. doi: 10.1186/s13063-026-09808-y.
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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.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing INTERCEPT Blood System for Red Blood Cells in people with Anemia, run by Cerus Corporation at 16 sites in 3 countries.
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 11 inclusion and 19 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Puerto Rico, Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adjusted hemoglobin increment (time frame: 15 minutes - 24 hours post transfusion). The study lists 3 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 NCT03037164, which also lists 1 linked publication.
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 6 Oct 2026.