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Resatorvid

Phase 3

Sepsis | Small molecule | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment277
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00143611Efficacy & Safety of Resatorvid in Adults With Severe SepsisPHASE3 COMPLETED 277Sep 1, 2005Feb 1, 2007Feb 2, 2012144 United States, Australia +15
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Study Endpoints
Primary Endpoints
28-day All-cause Mortality.
Day 28
Secondary Endpoints
Change from Baseline in Organ Failure Assessment
Day 28
Mean Systemic Inflammatory Response
Day 28
Mean Vasopressor-free days
Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Resatorvid 1.2 mg/kg/dayEXPERIMENTAL -
Resatorvid 2.4 mg/kg/dayEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ResatorvidDRUGResatorvid 1.2 mg/kg, injection, subcutaneously for thirty minutes; then resatorvid 0.05 mg/kg/h (1.2 mg/kg/day), injection, subcutaneously over 96 hours.
PlaceboDRUGResatorvid placebo-matching injection, subcutaneously for thirty minutes; then resatorvid placebo-matching injection, subcutaneously over 96 hours.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites144

Inclusion Criteria: * Has clinical evidence of infection defined as the presence of a known or probable source of infection requiring the initiation of parenteral antimicrobial therapy. * Must meet at least 3 of the following 4 criteria for SIRS: * A core temperature greater than 38°C or less th...

Countries:United StatesAustraliaAustriaBelgiumCanadaCzechiaFinlandGermanyIsraelItalyJapanNetherlandsNew ZealandPuerto RicoSpainSwedenUnited Kingdom
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