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Avotermin

Phase 2

Varicose Veins | Small molecule | Other |Icon Plc|Last Updated: Mar 9, 2010

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 Enrollment156
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00430326Juvista (Avotermin) in Scars Following Varicose Vein RemovalPHASE2 COMPLETED 156Nov 1, 2006Apr 1, 2009Mar 9, 201021 Belgium, Latvia +2
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Study Endpoints
Primary Endpoints
Investigator scar assessment
7 & 12 months
Patient scar assessment
up to 12 months
Independent scar assessment
7 & 12 months
Secondary Endpoints
Local tolerance
ongoing to 12 months
Adverse events
ongoing to12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
AvoterminDRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male and female patients between 18 and 85 years of age. * Patients undergoing surgical removal of bilateral varicose veins by ligation and stripping, which will result in clinically similar (i.e. size and location) wounds at the groin and knee. * Patients who have provided wr...

Countries:BelgiumLatviaLithuaniaUnited Kingdom
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