Focus: Assess Post Infusion Viability of S303 RBCsPhase 2S303 RBCNCT01711346
A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells
A Phase 2 study testing S303 Red Blood Cells (RBCs) and Conventional, untreated Red Blood Cells (RBCs) in people with Focus: Assess Post Infusion Viability of S303 RBCs, run by Cerus Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus: Assess Post Infusion Viability of S303 RBCs
- What is being tested?
- S303 Red Blood Cells (RBCs) and Conventional, untreated Red Blood Cells (RBCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoxworth Blood Center
Cincinnati, Ohio, 45267-0055
BloodCenter of Wisconsin Inc.
Milwaukee, Wisconsin, 53201
About this study
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
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.
- Being tested
- S303 Red Blood Cells (RBCs), Conventional, untreated Red Blood Cells (RBCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S303 Red Blood Cells (RBCs)Biological
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.
Conventional, untreated Red Blood Cells (RBCs)Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| S303 Red Blood Cells (RBCs) | Experimental | Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs). Receives: Biological: S303 Red Blood Cells (RBCs); Biological: Conventional, untreated Red Blood Cells (RBCs) |
| Conventional, Untreated Red Blood Cells (RBCs) | Active comparator | Participants will be assigned to Conventional, Untreated Red Blood Cells (RBCs) and then to S303 Red Blood Cells (RBCs). Receives: Biological: S303 Red Blood Cells (RBCs); Biological: Conventional, untreated Red Blood Cells (RBCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
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)
Measured: 70 Days
Primary Safety: Incidence of antibody specific to S 303 treated Red Blood Cells (RBCs)
Incidence of antibody specific to S 303 treated RBCs
Measured: 70 days
Secondary outcomes (4)
Secondary Safety: Incidence of adverse events
Incidence of adverse events
Measured: 70 Days
Secondary Efficacy Endpoint
Mean lifespan of autologous red blood cells (RBCs)
Measured: 70 days
Secondary Efficacy Endpoint:
Median lifespan (T50) of autologous red blood cells (RBCs)
Measured: 70 days
Secondary Efficacy Endpoint
Area under the curve (AUC) derived from data points collected for the red blood cell (RBC) lifespan
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Assess Post Infusion Viability of S303 RBCsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose A Cancelas-Perez, MD, PhD, Principal investigator, Hoxworth Blood Center, Cincinnati, OHJerome L Gottschall, MD, Principal investigator, BloodCenter of Wisconsin, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711346
- Sponsor's protocol ID
- CLI 00073
- Acronym
- S303 RBC
- Status last verified
- Dec 2015
- First submitted
- 17 Oct 2012
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01711346
- Acronym / sponsor ID
- S303 RBC / CLI 00073
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S303 Red Blood Cells (RBCs) | Experimental | Biological: S303 Red Blood Cells (RBCs), Biological: Conventional, untreated Red Blood Cells (RBCs)Participants will be assigned to S303 Red Blood Cells (RBCs) and then to Conventional, Untreated Red Blood Cells (RBCs). |
| Conventional, Untreated Red Blood Cells (RBCs) | Active comparator | Biological: S303 Red Blood Cells (RBCs), Biological: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- • Clinically significant acute or chronic disease (as determined by the Investigator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S303 Red Blood Cells (RBCs)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. | Biological | Conventional, Untreated Red Blood Cells (RBCs), S303 Red Blood Cells (RBCs) |
| Conventional, untreated Red Blood Cells (RBCs)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. | Biological | Conventional, Untreated Red Blood Cells (RBCs), S303 Red Blood Cells (RBCs) |
Primary outcome
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days
Time frame: 70 Days
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
Incidence of antibody specific to S 303 treated RBCs
4 secondary outcomes
Secondary Safety: Incidence of adverse events
Time frame: 70 Days
Secondary Efficacy Endpoint
Time frame: 70 days
Secondary Efficacy Endpoint:
Time frame: 70 days
Secondary Efficacy Endpoint
Time frame: 70 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose A Cancelas-Perez, MD, PhD principal investigator
Hoxworth Blood Center, Cincinnati, OH
Jerome L Gottschall, MD principal investigator
BloodCenter of Wisconsin, Milwaukee, WI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S303 Red Blood Cells (RBCs) and Conventional, untreated Red Blood Cells (RBCs) in people with Focus: Assess Post Infusion Viability of S303 RBCs, run by Cerus Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy: 24 hour post-infusion recovery of autologous Red Blood Cells (RBCs) stored for 35 days (time frame: 70 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.