A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S 303 Treated Red Blood Cells (S 303 RBC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Cerus Corporation
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation
ClinicalTrials.gov Identifier:
NCT01711346
First received: October 17, 2012
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.


Condition Intervention Phase
Focus: Assess Post Infusion Viability of S303 RBCs
Biological: S303 Red Blood Cells (RBCs)
Biological: Conventional, untreated Red Blood Cells (RBCs)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S 303 Treated Red Blood Cells

Further study details as provided by Cerus Corporation:

Primary Outcome Measures:
  • Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days [ Time Frame: 70 Days ] [ Designated as safety issue: No ]
    24 hour post-infusion recovery of autologous RBCs stored for 35 days (assessed using the Food and Drug Administration (FDA)) criteria for evaluation of in vivo RBC studies)

  • Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs) [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
    Incidence of antibody specific to S 303 treated RBCs


Secondary Outcome Measures:
  • Secondary Safety: Incidence of adverse events [ Time Frame: 70 Days ] [ Designated as safety issue: Yes ]
    Incidence of adverse events

  • Secondary Efficacy Endpoint [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    Mean lifespan of autologous red blood cells (RBCs)

  • Secondary Efficacy Endpoint: [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    Median lifespan (T50) of autologous red blood cells (RBCs)

  • Secondary Efficacy Endpoint [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan


Estimated Enrollment: 28
Study Start Date: October 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S303 Red Blood Cells (RBCs)
The subjects will be randomly assigned to the sequence of administration of Test and Control RBCs; eligible subjects are randomly assigned to receive Test RBCs followed by Control RBCs, or Control RBCs followed by Test RBCs.
Biological: S303 Red Blood Cells (RBCs)
Active Comparator: Conventional, Untreated Red Blood Cells (RBCs)
The subjects will be randomly assigned to the sequence of administration of Test and Control RBCs; eligible subjects are randomly assigned to receive Test RBCs followed by Control RBCs, or Control RBCs followed by Test RBCs.
Biological: Conventional, untreated Red Blood Cells (RBCs)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age at least 18 years, of either gender
  • Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
  • Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC distribution width(RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea nitrogen (BUN), creatinine). Values outside of normal reference range thought not to be clinically significant may be allowed with a protocol exception.
  • Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects
  • Negative blood donor screening test panel for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV), Syphilis, and west nile virus (WNV) (if available)
  • Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
  • Meet or exceed American Association of Blood Banks (AABB) guidelines for blood donation (with the exception of travel deferrals).
  • Signed and dated informed consent form

Exclusion Criteria:

  • • Clinically significant acute or chronic disease (as determined by the Investigator)

    • History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies, or autoimmune disease
    • History of congenital red cell disorders including glucose 6 phosphate dehydrogenase (G-6PD) deficiency
    • Serum ferritin <12 ng/mL
    • Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at study entry
    • Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the past 28 days
    • Treatment with any medication known to affect RBC viability
    • Pregnant or nursing female
    • Male subjects or female subjects of childbearing potential not using effective contraception
    • Participation in another clinical study currently or within the past 28 days
    • Prior exposure to S 303 treated RBCs
    • Pre-existing antibody specific to S 303 treated RBCs
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711346

Locations
United States, Ohio
Hoxworth Blood Center Completed
Cincinnati, Ohio, United States, 45267-0055
United States, Wisconsin
BloodCenter of Wisconsin Inc. Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Sharon Graminske       sharon.graminske@bcw.edu   
Principal Investigator: Jerome L Gottschall, MD         
Sponsors and Collaborators
Cerus Corporation
Investigators
Principal Investigator: Jose A Cancelas-Perez, MD, PhD Hoxworth Blood Center, Cincinnati, OH
Principal Investigator: Jerome L Gottschall, MD BloodCenter of Wisconsin, Milwaukee, WI
  More Information

No publications provided

Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT01711346     History of Changes
Other Study ID Numbers: CLI 00073
Study First Received: October 17, 2012
Last Updated: October 17, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 23, 2014