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INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037164
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation

Brief Summary:

Stage A: 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.

Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in regions where a substantial proportion of the population has been infected or is at risk of a transfusion-transmissible infection.

The objectives and design of Stage B will be reassessed on the completion of Stage A, in consultation with the FDA.


Condition or disease Intervention/treatment Phase
Anemia Device: INTERCEPT Blood System for Red Blood Cells Device: Conventional (Control) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Controlled, Parallel Group Study With the INTERCEPT Blood System for RBCs in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections and Treatment Use Open-Label Extension Study
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: INTERCEPT (Test)
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
Device: INTERCEPT Blood System for Red Blood Cells
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.

Active Comparator: 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)
Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care




Primary Outcome Measures :
  1. 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)

  2. 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.

  3. Treatment emergent antibodies [ Time Frame: 75 days ]
    The proportion of patients with treatment emergent antibodies with confirmed specificity to IBS RBCs


Secondary Outcome Measures :
  1. Adjusted hemoglobin consumption [ Time Frame: 211 Days ]
    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.

  2. HbA clearance [ Time Frame: 211 days ]
    HbA clearance in patients with SCD undergoing regular repeated RCE

  3. Adverse Events [ Time Frame: 28 Days after last study transfusion ]
    Treatment-emergent AEs

  4. Transfusion reactions related to study RBCs (test or control) [ Time Frame: 28 Days after last study transfusion ]
    Defined by the CDC National Healthcare Safety Network [NHSN] Hemovigilance Module protocol

  5. RBC allo-antigens [ Time Frame: 28 days ]
    Treatment-emergent immunization to RBC allo-antigens

  6. Mortality [ Time Frame: 28 Days after last study transfusion ]
    All-cause mortality

  7. Adverse Events of Special Interest (AESI) [ Time Frame: 28 Days after last study RCE ]
    Proportion of subjects with adverse events of special interest (AESI) through 28 days after the last study transfusion.

  8. S-300 and GSH plasma levels [ Time Frame: 15 minutes to 4 hrs after RCE ]
    S-300 and Glutathione (GSH) plasma levels



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Stage A: Inclusion Criteria:

  • 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 prior to study treatment 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 chronically transfused patients:

• 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 transfusion episodes

Stage A: Exclusion Criteria

  • 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.
  • Have had an RBC transfusion within 7 days prior to randomization.
  • 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 red cell exchange 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 repeated RCE 28-day +6-month 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037164


Contacts
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Contact: Chris Marston 1-949-275-8702 cmarston@cerus.com
Contact: Nell Shimasaki 1-925-288-6116 nshimasaki@cerus.com

Locations
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United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Florida
Mayo Clinic Jacksonville Active, not recruiting
Jacksonville, Florida, United States, 32224
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Ross Fasano, MD       scdresearch@emory.edu   
Contact: Hailly Butler, BSN         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ravi Sarode, MD       Ravi.Sarode@UTSouthwestern.edu   
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77303
Contact: Arthur Bracey, MD       arthur.bracey@commonspirit.org   
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Jeffrey A Green, Dr       jeffrey.green@vcuhealth.org   
Puerto Rico
Menonita General Hospital Active, not recruiting
Aibonito, Puerto Rico, 00705
HIMA San Pablo Hospital Active, not recruiting
Caguas, Puerto Rico, 00725
San Juan Bautista School of Medicine Clinical Research Unit Active, not recruiting
Caguas, Puerto Rico, 00725
Sponsors and Collaborators
Cerus Corporation
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Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT03037164    
Other Study ID Numbers: CLI 00126
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Cerus Corporation:
INTERCEPT
Red Blood Cells
RBC
Pathogen Inactivation
Zika
Cerus
Pathogen Reduction
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases