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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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