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Epo-alpha

Phase 3

Resuscitation | Small molecule | Other |Johnson & Johnson|Last Updated: May 17, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00719498Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)PHASE3 COMPLETED 20Nov 1, 2003Jul 1, 2004May 17, 2011 -
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Study Endpoints
Primary Endpoints
Primary: Mortality and neurological outcome recorded at day 28
Secondary Endpoints
All unexpected events in order to detect potential side effects of High-dose Epo administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Epo-alphaDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients who have OHCA of presumed cardiac origin * Patient's who have delay between the collapse and onset of cardiopulmonary resuscitation (CPR, no flow) less that 10 minutes * Patient's who have delay between onset of CPR and return of spontaneous circulation (ROSC, low flo...

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