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TISSEEL VH fibrin sealant

Phase 3

Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy | Small molecule | Other |Baxter International Inc.|Last Updated: Apr 5, 2017

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00161733Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac SurgeryPHASE3 COMPLETED -Sep 1, 2002Nov 1, 2004Apr 5, 201722 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)DRUG -
TISSEEL VH fibrin sealantDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: All subjects accepted for this study must be: * Informed of the nature of the study and have provided written informed consent * \>= 18 years of age * Scheduled to undergo cardiac surgery requiring CPB and median sternotomy * Able and willing to comply with the procedures requi...

Countries:United States
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