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Fibrin Sealant

Phase 3

Esophageal and/or Gastric Varices | Small molecule | Gastrointestinal |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
NCT00161915Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal VaricesPHASE3 COMPLETED -Dec 1, 2000Jan 1, 2004Oct 23, 200612 Germany
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Fibrin SealantDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis: * with a minimum age of 18 years, * with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to ho...

Countries:Germany
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