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eythrocytapheresis, whole blood collection

Phase 3

Pre Operative Autologous Donation | Unknown | Other |Atrium Therapeutics, Inc.|Last Updated: Oct 20, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
ACTIVE_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00202475Collection of Autologous Blood Products by Double ErythrocytapheresisPHASE3 COMPLETED 100 — — Sep 1, 2003Dec 1, 2007Oct 20, 20092 Netherlands
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Study Endpoints
Primary Endpoints
decline in Hemoglobine levels
surgery
Secondary Endpoints
Storage parameters- ATP
35 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
eythrocytapheresisPROCEDUREmachinal collection of erythrocytes
whole blood collectionPROCEDUREcollection of whole blood
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Elective surgery Exclusion Criteria: * Malignancies * Severe arrhythmias * Congestive heart failure * Recent angina * Epileptic seizures in the last 3 months before collection

Countries:Netherlands
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