Clinical trial NCT01711346: A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Focus: Assess Post Infusion Viability of S303 RBCs
Lead sponsor: Cerus Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
timeFrame: 70 Days
measure: Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
timeFrame: 70 days
Secondary outcomes:
measure: Secondary Safety: Incidence of adverse events
timeFrame: 70 Days
measure: Secondary Efficacy Endpoint
timeFrame: 70 days
measure: Secondary Efficacy Endpoint:
timeFrame: 70 days
measure: Secondary Efficacy Endpoint
timeFrame: 70 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin Inc.
state: Wisconsin
Study officials:
affiliation: Hoxworth Blood Center, Cincinnati, OH
name: Jose A Cancelas-Perez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: BloodCenter of Wisconsin, Milwaukee, WI
name: Jerome L Gottschall, MD
role: PRINCIPAL_INVESTIGATOR
References: