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Protein C Vapor Heated

Phase 2

Protein C Deficiency | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 5, 2021

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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00157118Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C DeficiencyPHASE2 COMPLETED 18Aug 22, 2003Mar 17, 2005May 5, 202112 United States
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Study Endpoints
Primary Endpoints
Whether episodes of purpura fulminans, Coumarin-induced skin necrosis and/or other thromboembolic event could be treated effectively, effectively with complications, or not treated effectively with Protein C Concentrate.
Part 1 of the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Protein C Concentrate (Human) Vapor HeatedDRUG -
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Newborn subjects \<= 6 months of age: diagnosis of severe congenital protein C deficiency, with documented functional protein C level \< 20%. If a genetic diagnosis is not available prior to initiation of Protein C Concentrate treatment, a documented family history of protein ...

Countries:United States
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