ACTIVE_NOT_RECRUITING

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

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Conditions

AnemiaINTERCEPTRed Blood CellsRBCPathogen InactivationZikaCerusPathogen Reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2017-05-11
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03037164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 4 years.
  2. * Patients who require or are expected to require a transfusion of RBC component(s), including red cell exchange transfusion
  3. * Signed and dated informed consent form.
  4. * Female patients of child-bearing potential must:
  5. * Have negative serum or urine pregnancy tests prior to study treatment to rule out pregnancy, and
  6. * 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.
  7. * Diagnosis of SCD, either HbSS, HbSC or HbSB0 thalassemia, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high-performance liquid chromatography (HPLC)
  8. * 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
  9. * 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
  10. * Pregnant or breast feeding.
  11. * Presence of an RBC warm autoantibody with evidence of active hemolysis.
  12. * Positive DAT as defined below:
  13. * A polyspecific-DAT reaction strength \> 2+, or
  14. * 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.
  15. * Have had an RBC transfusion within 7 days prior to randomization.
  16. * 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.
  17. * 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.
  18. * Patients who require neonatal transfusions and intrauterine transfusions.
  19. * Pre-existing antibody to RBC antigens that may make the provision of compatible study RBC components difficult.
  20. * History of transfusion reactions requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
  21. * Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
  22. * For SCD patients to be enrolled into the repeated RCE 28-day +6-month arm of the study:
  23. * A history of acute chest syndrome in the last 6 months, or hyperhemolysis syndrome at any time.
  24. * 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).
  25. * 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.
  26. * Subject is in active treatment with renal dialysis.
  27. * 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.
  28. * Subject with known G6PD deficiency or requiring treatment with medications that are known to adversely affect RBC viability or bone marrow function.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Cerus Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-11
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2017-05-11
Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

  • INTERCEPT
  • Red Blood Cells
  • RBC
  • Pathogen Inactivation
  • Zika
  • Cerus
  • Pathogen Reduction

Additional Relevant MeSH Terms

  • Anemia