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autologous stored platelets

Phase 2

Bleeding | Monoclonal antibody | Other |Novo Nordisk A/S|Last Updated: Apr 28, 2011

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
UNCONTROLLED
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01248351Reversibility of Dual Antiplatelet Therapy by PlateletsPHASE2 COMPLETED 6Nov 1, 2010Mar 1, 2011Apr 28, 20111 Austria
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Study Endpoints
Primary Endpoints
Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP
7 days

pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter

Secondary Endpoints
Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid
7 days
Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI)
7 days
Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %)
7 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
autologous stored plateletsEXPERIMENTAL -
Interventions
NameTypeDescription
autologous stored plateletsOTHERAdministration of autologous stored platelets
administration of autologous stored plateletsOTHERadministration of autologous stored platelets
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Eligibility Criteria
Age Range18 Years — 30 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Informed consent 2. Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted) 3. Age of consent 4. Weight: 70 kg - 100 kg 5. Platelet count 240 000 to 440 000/µL 6. Hematocrit \> 40% 7. readiness...

Countries:Austria
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