- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01711346
A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells (S303 RBC)
December 3, 2015 updated by: Cerus Corporation
A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267-0055
- Hoxworth Blood Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- BloodCenter of Wisconsin Inc.
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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.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: S303 Red Blood Cells (RBCs)
Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs).
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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.
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.
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Active Comparator: Conventional, Untreated Red Blood Cells (RBCs)
Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs).
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
Time Frame: 70 Days
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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)
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70 Days
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Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
Time Frame: 70 days
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Incidence of antibody specific to S 303 treated RBCs
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70 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety: Incidence of adverse events
Time Frame: 70 Days
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Incidence of adverse events
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70 Days
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Secondary Efficacy Endpoint
Time Frame: 70 days
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Mean lifespan of autologous red blood cells (RBCs)
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70 days
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Secondary Efficacy Endpoint:
Time Frame: 70 days
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Median lifespan (T50) of autologous red blood cells (RBCs)
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70 days
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Secondary Efficacy Endpoint
Time Frame: 70 days
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Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan
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70 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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 Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
October 17, 2012
First Submitted That Met QC Criteria
October 18, 2012
First Posted (Estimate)
October 22, 2012
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 3, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- CLI 00073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
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Emory UniversityCompletedCardiovascular DiseasesUnited States
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