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Tifacogin

Phase 3

Pneumonia | Small molecule | Infectious Disease |Novartis AG|Last Updated: Dec 19, 2020

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment2,136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00084071Tifacogin for the Treatment of Patients With Severe Community-Acquired PneumoniaPHASE3 COMPLETED 2,136May 1, 2004Jul 1, 2008Dec 19, 2020150 United States, Argentina +16
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Study Endpoints
Primary Endpoints
Compare the effect of tifacogin vs placebo administration.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
TifacoginDRUG -
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites150

Inclusion Criteria: * Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence * Pneumonia of sufficient severity to require ICU admission and management Exclusion Criteria: * Pregnancy * Weight over 150 kg * Patients at increased risk...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileFranceGermanyMalaysiaNetherlandsNew ZealandPeruSingaporeSouth AfricaSouth KoreaSpainUnited Kingdom
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