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Fibrin Sealant VH S/D

Phase 3

Breast Cancer | Small molecule | Oncology |Baxter International Inc.|Last Updated: Oct 23, 2006

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 Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00161980Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection SitesPHASE3 COMPLETED -Jun 1, 2001Dec 1, 2002Oct 23, 20068 Austria, France +2
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Fibrin Sealant VH S/DDRUG -
Surgical intervention alone without Fibrin Sealant VH S/D applicationPROCEDURE -
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Eligibility Criteria
Age Range19 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Written informed consent has been obtained from the subject prior to FS VH S/D administration * Female subjects \>= 19 years of age * Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I and II axillary lymphadenectomy with two separate incisio...

Countries:AustriaFranceGermanyItaly
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Competitive Landscape -Breast Cancer 408 trials
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Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
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Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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