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rFIX

Phase 3

Hemophilia B | Small molecule | Hematology |Pfizer, Inc.|Last Updated: Aug 21, 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
RandomizedUNCONTROLLED
Total Trials2
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00093171Study Evaluating rFIX; BeneFIX® in Hemophilia BPHASE3 COMPLETED 23 -May 1, 2005Aug 21, 20097 United States
NCT00093210Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia BPHASE3 COMPLETED - -Sep 1, 2005Dec 5, 2007 -
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
rFIXDRUG -
rFIX-RDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Hemophilia B (FIX:C less than 2%) * Previous treatment of at least 150 exposure days using any FIX product * 12 years of age and older Exclusion Criteria: * The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors...

Countries:United States
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