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S-303 Red Blood Cells- Test

Phase 3

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

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

Clinical trial landscape

S-303 Red Blood Cells- Test · 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 S-303 Red Blood Cells- Test

What is S-303 Red Blood Cells used for?

S-303 Red Blood Cells is an investigational pathogen-reduced red blood cell product being studied for transfusion support in patients with acute anemia. It is designed to assess post-infusion viability of treated red blood cells and their safety and efficacy in patients requiring transfusion support.

Who makes S-303 Red Blood Cells?

S-303 Red Blood Cells is being developed by Cerus Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol CERS. The company is conducting clinical studies to evaluate the product's viability and efficacy in transfusion settings.

What phase is S-303 Red Blood Cells in?

S-303 Red Blood Cells is in Phase 3 clinical development. A Phase 3 study has been completed to evaluate its safety and efficacy in patients with acute anemia requiring transfusion support. The product remains investigational and is not yet approved for commercial use.

What clinical trials is S-303 Red Blood Cells in?

S-303 Red Blood Cells has been studied in two completed trials. NCT01711346 assessed the recovery and lifespan of radiolabeled autologous S303-treated red blood cells in healthy volunteers. NCT01716923 evaluated safety and efficacy in patients with acute anemia requiring transfusion support.

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

Yes, S-303 Red Blood Cells is also referred to as S303 RBCs. The product is a pathogen-reduced red blood cell preparation developed by Cerus Corporation, and clinical trials use the S303 RBCs terminology to describe the investigational treatment.