Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation

Brief Summary:

Stage A: To evaluate the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in adult 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 infection by the Zika virus (ZIKV), 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. Dengue and Chikungunya), and to 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

  Show Detailed Description

Layout table for study information
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 : June 30, 2020
Estimated Study Completion Date : December 30, 2020

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 averaged over multiple transfusions [ Time Frame: 1-4 hours post transfusion ]
    The difference between the hemoglobin value most proximate before each transfusion and approximately 1-4h post transfusion adjusted by hemoglobin content transfused

  2. Adverse Events [ Time Frame: 75 days ]
    The proportion of patients with AEs possibly, probably or definitely related to RBC 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: 75 Days ]
    Hemoglobin consumption is measured as the hemoglobin mass transfused per patient adjusted for episode-specific body weight and duration of transfusion support (Hb g per kg body weight per day)

  2. Adverse Events [ Time Frame: 75 Days ]
    Treatment-emergent AEs

  3. Transfusion reactions [ Time Frame: 75 Days ]
    Defined by the CDC NHSN Hemovigilance Module protocol

  4. RBC allo-antigens [ Time Frame: 75 days ]
    Treatment-emergent immunization to RBC allo-antigens

  5. Mortality [ Time Frame: 75 Days ]
    All-cause mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Stage A: Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients who are required or expected to require a transfusion of RBC component(s).
  3. Signed and dated informed consent
  4. Female patients of child-bearing potential must:

    1. Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
    2. Agree to use at least one medically accepted 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, sexual abstinence or vasectomized partner for the duration of study participation and for an additional 28 days.

Stage A: Exclusion Criteria:

  1. Confirmed positive baseline serum/plasma antibody specific to IBS RBC as determined by INTERCEPT antibody screening panel prior to receiving their first study transfusion
  2. Pregnant or breast feeding.
  3. Patients who require neonatal transfusions and intrauterine transfusions.
  4. Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
  5. Presence of a RBC warm autoantibody or positive DAT with a panreactive eluate.
  6. Have had an RBC transfusion during current hospitalization prior to enrollment (within 28 days)
  7. Have received investigational products, including investigational blood products, pharmacologic agents or imaging materials, within the prior 28 days. Prior receipt of conventional blood products tested with an investigational ZIKV NAT test are not considered grounds for exclusion despite the investigational nature of the NAT test.
  8. Patients presenting with or expected to have massive hemorrhage (≥10 RBC units within 24 hours) or expected to require massive transfusion protocols

Stage B: Inclusion Criteria

  1. Age ≥ 18 years
  2. Patients who are require or expected to require a transfusion of RBC component(s).
  3. Signed and dated informed consent

Stage B: Exclusion Criteria

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

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
Layout table for location contacts
Contact: Chris Marston 1-949-275-8702 cmarston@cerus.com
Contact: Nell Shimasaki 1-925-288-6116 nshimasaki@cerus.com

Locations
Layout table for location information
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Abba Zubair, MD       zubair.abba@mayo.edu   
OneBlood Active, not recruiting
Orlando, Florida, United States, 32819
United States, Texas
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   
Banco de Sangre de Servicios Mutuos, Inc. (BSSM) Recruiting
Guaynabo, Puerto Rico, 00968
Contact: Gerardo Latoni, MD       glatoni@bssmpr.com   
Sponsors and Collaborators
Cerus Corporation
Investigators
Layout table for investigator information
Principal Investigator: Edgardo F Cartagena, Dr San Juan Bautista School of Medicine Clinical Research Unit

Layout table for additonal information
Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT03037164     History of Changes
Other Study ID Numbers: CLI 00126
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: May 2019

Layout table for additional information
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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Cerus Corporation:
INTERCEPT
Red Blood Cells
RBC
Pathogen Inactivation
Zika
Cerus
Pathogen Reduction

Additional relevant MeSH terms:
Layout table for MeSH terms
Transfusion Reaction
Hematologic Diseases
Immune System Diseases