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

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ClinicalTrials.gov Identifier: NCT03037164
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : April 2, 2021
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, and the risk of asymptomatic infection among qualified blood donors is recognized. Besides the reduction of risk of transfusion transmitted ZIKV, the intent of the study is also to reduce the risk of transfusion-transmitted infections (TTI) in general, including transfusion related sepsis and other emerging or concurrent endemic pathogens (e.g., SARS-CoV-2, Dengue and Chikungunya), and to potentially reduce the risk of TA-GVHD.

As part of this treatment use study, additional data will be provided on the safety of INTERCEPT-treated RBCs (IBS RBCs) supplied for routine clinical transfusion practice.


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 : 600 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, 2021
Estimated Study Completion Date : January 30, 2022

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

  3. 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

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

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



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
  • Female patients of child-bearing potential must:

    • Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
    • 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

Stage A: Exclusion Criteria

  • Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S-303 treated RBC) as determined by INTERCEPT antibody screening panel prior to receiving the first study transfusion
  • Pregnant or breast feeding.
  • Presence of a RBC warm autoantibody
  • 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 14 days prior to S-303 antibody screen for eligibility
  • Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within the prior 28 days to randomization. Prior receipt of conventional blood products tested with an investigational NAT test are not considered grounds 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
  • Subjects on regular long-term red cell exchange protocols will not be enrolled into the 6-month extension option

Stage B: Inclusion Criteria

  • Age ≥ 4 years
  • Patients expected to require or requiring a transfusion of RBC component(s), including red cell exchange transfusion.
  • Signed and dated informed consent and assent (if applicable)
  • Female patients of child-bearing potential must:

    • Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
    • 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

Stage B: Exclusion Criteria

  • Confirmed positive baseline serum/plasma antibody specific to IBS RBC as determined by antibody screening panel to S-303 treated RBC prior to receiving their first study transfusion.
  • Pregnant or breast feeding.
  • Patients who require neonatal transfusions and intrauterine transfusions.
  • Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
  • 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

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 Recruiting
New Haven, Connecticut, United States, 06520
Contact: Edward Snyder, MD    203-688-2443      
Principal Investigator: Edward Snyder, MD         
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: Elizabeth Hartwell, MD       hartwell@bcm.edu   
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 Recruiting
Aibonito, Puerto Rico, 00705
Contact: Lumen Vera, Dr.       lvera@mghpr.org   
HIMA San Pablo Hospital Recruiting
Caguas, Puerto Rico, 00725
Contact: Bolivar Arboleda, Dr.    787-653-3434      
San Juan Bautista School of Medicine Clinical Research Unit Recruiting
Caguas, Puerto Rico, 00725
Contact: Edgardo Cartagena, Dr.       ecartagena@sanjuanbautista.edu   
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: April 2, 2021
Last Verified: March 2021

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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