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S303 Red Blood Cells

Phase 3

Focus:Use of S303 RBCs in Patients With Acute Anemia | Monoclonal antibody | Hematology |Cerus Corporation|Trials Updated: Aug 26, 2015

S303 Red Blood Cells target and mechanism

ModalityMonoclonal antibody

Also known as S303 Red Blood Cells (RBCs), S-303 Red Blood Cells (RBCs) - Test, S-303 Red Blood Cells- Test

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

S303 Red Blood Cells clinical trials

S303 Red Blood Cells · 1 trial · 1 indication

Phase 3 1
NCT01716923Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute AnemiaFocus:Use of S303 RBCs in Patients With Acute Anemia
COMPLETED81 Analytics
PHASE3COMPLETED
Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia
Focus:Use of S303 RBCs in Patients With Acute AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary Efficacy Endpoint - mean hemoglobin content
Day 2

The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups

Primary Safety Endpoint - Adverse events
90 days

The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.

Secondary Endpoints

Secondary Efficacy Endpoint
Day 35
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
S-303 Treated Red Blood CellsEXPERIMENTALPatients receive S-303 treated red blood cells (RBCs).
Conventional, untreated Red Blood CellsACTIVE_COMPARATORPatients receive conventional, untreated red blood cells (RBCs).

Interventions

NameTypeDescription
S-303 Red Blood Cells (RBCs) - TestBIOLOGICAL -
Conventional, untreated red blood cells (RBCs) - ControlBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Age ≥18 years, of either gender. 2. Must be willing to use an acceptable form of contraceptive while on study (as approved by the Investigator or designee) 3. Must be readily available by telephone 4. Must provide an informed consent for study participation and have signed an...

Countries:Germany
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Frequently asked questions about S303 Red Blood Cells

What is S303 Red Blood Cells?

S303 Red Blood Cells is an investigational blood product developed by Cerus Corporation for transfusion support in patients with acute anemia. It is being studied as an alternative to conventional red blood cell transfusions. The program reached Phase 3 clinical development in hematology.

What is S303 Red Blood Cells used for?

S303 Red Blood Cells is being developed for transfusion support in patients with acute anemia. The focus is on patients who require red blood cell transfusion, with the goal of providing a pathogen-reduced red blood cell component for that support.

Who makes S303 Red Blood Cells?

Cerus Corporation, which trades on the Nasdaq under the ticker CERS, is developing S303 Red Blood Cells. The company is the sponsor of the clinical program evaluating the product in patients with acute anemia.

What phase is S303 Red Blood Cells in?

S303 Red Blood Cells has completed a Phase 3 clinical trial. It is an investigational product and is not described as approved; the Phase 3 study has finished and no trials are currently listed as active.

What clinical trials is S303 Red Blood Cells in?

S303 Red Blood Cells was studied in NCT01716923, a Phase 3 trial titled Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia. The trial enrolled 81 patients in Germany, was randomized, double blind, and active controlled, and is completed.

Is S303 Red Blood Cells the same as S-303 Red Blood Cells?

Yes. S303 Red Blood Cells is also referred to as S303 Red Blood Cells (RBCs), S-303 Red Blood Cells (RBCs) - Test, and S-303 Red Blood Cells - Test. These names refer to the same Cerus Corporation red blood cell product in development for acute anemia transfusion support.