<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711346</url>
  </required_header>
  <id_info>
    <org_study_id>CLI 00073</org_study_id>
    <nct_id>NCT01711346</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells</brief_title>
  <acronym>S303 RBC</acronym>
  <official_title>A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cerus Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cerus Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells&#xD;
      (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs&#xD;
      prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to&#xD;
      conventional untreated RBCs stored for 35 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days</measure>
    <time_frame>70 Days</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)</measure>
    <time_frame>70 days</time_frame>
    <description>Incidence of antibody specific to S 303 treated RBCs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Safety: Incidence of adverse events</measure>
    <time_frame>70 Days</time_frame>
    <description>Incidence of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint</measure>
    <time_frame>70 days</time_frame>
    <description>Mean lifespan of autologous red blood cells (RBCs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint:</measure>
    <time_frame>70 days</time_frame>
    <description>Median lifespan (T50) of autologous red blood cells (RBCs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint</measure>
    <time_frame>70 days</time_frame>
    <description>Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Focus: Assess Post Infusion Viability of S303 RBCs</condition>
  <arm_group>
    <arm_group_label>S303 Red Blood Cells (RBCs)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional, Untreated Red Blood Cells (RBCs)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>S303 Red Blood Cells (RBCs)</intervention_name>
    <description>Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.</description>
    <arm_group_label>Conventional, Untreated Red Blood Cells (RBCs)</arm_group_label>
    <arm_group_label>S303 Red Blood Cells (RBCs)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Conventional, untreated Red Blood Cells (RBCs)</intervention_name>
    <description>Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.</description>
    <arm_group_label>Conventional, Untreated Red Blood Cells (RBCs)</arm_group_label>
    <arm_group_label>S303 Red Blood Cells (RBCs)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age at least 18 years, of either gender&#xD;
&#xD;
          -  Normal health status (as determined by the Investigator review of medical history and&#xD;
             blood donor physical exam)&#xD;
&#xD;
          -  Complete blood count (CBC); including red blood cell (RBC) indices mean cell volume&#xD;
             (MCV), mean cell hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and RBC&#xD;
             distribution width(RDW) and serum chemistry values within normal limits (including&#xD;
             calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol,&#xD;
             glucose, total protein, triglycerides, lactate dehydrogenase (LDH), alanine&#xD;
             aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea&#xD;
             nitrogen (BUN), creatinine). Values outside of normal reference range thought not to&#xD;
             be clinically significant may be allowed with a protocol exception.&#xD;
&#xD;
          -  Minimum hemoglobin levels of 13 g/dL for female and 14.5 g/dL for male subjects&#xD;
&#xD;
          -  Negative blood donor screening test panel for human immunodeficiency virus (HIV),&#xD;
             Hepatitis B virus (HBV), Hepatitis C virus (HCV), human T cell leukemic virus (HTLV),&#xD;
             Syphilis, and west nile virus (WNV) (if available)&#xD;
&#xD;
          -  Female subjects of childbearing potential and male subjects must agree to use a&#xD;
             medically acceptable method of contraception throughout the study periods. A barrier&#xD;
             method of contraception must be included, regardless of other methods.&#xD;
&#xD;
          -  Meet or exceed American Association of Blood Banks (AABB) guidelines for blood&#xD;
             donation (with the exception of travel deferrals).&#xD;
&#xD;
          -  Signed and dated informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Clinically significant acute or chronic disease (as determined by the Investigator)&#xD;
&#xD;
               -  History of RBC autoantibodies/autoimmune hemolytic anemia, RBC allo-antibodies,&#xD;
                  or autoimmune disease&#xD;
&#xD;
               -  History of congenital red cell disorders including glucose 6 phosphate&#xD;
                  dehydrogenase (G-6PD) deficiency&#xD;
&#xD;
               -  Serum ferritin &lt;12 ng/mL&#xD;
&#xD;
               -  Positive direct antiglobulin test (DAT) or indirect antiglobulin test (IAT) at&#xD;
                  study entry&#xD;
&#xD;
               -  Immunosuppressive therapy (e.g., oral or Intravenous (IV) prednisone) within the&#xD;
                  past 28 days&#xD;
&#xD;
               -  Treatment with any medication known to affect RBC viability&#xD;
&#xD;
               -  Pregnant or nursing female&#xD;
&#xD;
               -  Male subjects or female subjects of childbearing potential not using effective&#xD;
                  contraception&#xD;
&#xD;
               -  Participation in another clinical study currently or within the past 28 days&#xD;
&#xD;
               -  Prior exposure to S 303 treated RBCs&#xD;
&#xD;
               -  Pre-existing antibody specific to S 303 treated RBCs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose A Cancelas-Perez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hoxworth Blood Center, Cincinnati, OH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jerome L Gottschall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BloodCenter of Wisconsin, Milwaukee, WI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoxworth Blood Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BloodCenter of Wisconsin Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <disposition_first_submitted>September 14, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 14, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 30, 2015</disposition_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711346
org study id: CLI 00073
nct id: NCT01711346
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
time frame: 70 Days
description: 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)
measure: Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
time frame: 70 days
description: Incidence of antibody specific to S 303 treated RBCs
measure: Secondary Safety: Incidence of adverse events
time frame: 70 Days
description: Incidence of adverse events
measure: Secondary Efficacy Endpoint
time frame: 70 days
description: Mean lifespan of autologous red blood cells (RBCs)
measure: Secondary Efficacy Endpoint:
time frame: 70 days
description: Median lifespan (T50) of autologous red blood cells (RBCs)
measure: Secondary Efficacy Endpoint
time frame: 70 days
description: Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan
arm group label: S303 Red Blood Cells (RBCs)
arm group type: Experimental
description: Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).
arm group label: Conventional, Untreated Red Blood Cells (RBCs)
arm group type: Active Comparator
description: Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).
intervention type: Biological
intervention name: S303 Red Blood Cells (RBCs)
description: Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
arm group label: Conventional, Untreated Red Blood Cells (RBCs)
arm group label: S303 Red Blood Cells (RBCs)
intervention type: Biological
intervention name: Conventional, untreated Red Blood Cells (RBCs)
description: Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
arm group label: Conventional, Untreated Red Blood Cells (RBCs)
arm group label: S303 Red Blood Cells (RBCs)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jose A Cancelas-Perez, MD, PhD
role: Principal Investigator
affiliation: Hoxworth Blood Center, Cincinnati, OH
last name: Jerome L Gottschall, MD
role: Principal Investigator
affiliation: BloodCenter of Wisconsin, Milwaukee, WI
facility: 
facility: 
country: United States
responsible party type: Sponsor