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Ivermectin

Phase 3

Chronic Strongyloidiasis | Small molecule | Other |Atlantic International Corp.|Last Updated: Sep 7, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00765024Ivermectin Versus Albendazole for Chronic StrongyloidiasisPHASE3 COMPLETED 90Jul 1, 2008Apr 1, 2010Sep 7, 20171 Thailand
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Study Endpoints
Primary Endpoints
cure rate
1 year
Secondary Endpoints
safety
1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AlbendazoleACTIVE_COMPARATORAlbendazole for 7 days
ivermectinEXPERIMENTALivermectin 200 mcg/kg single dose
ivermectin 2 dosesEXPERIMENTALivermectin 200 mcg/kg two doses in 2 weeks
Interventions
NameTypeDescription
IvermectinDRUGsingle dose of 200 mcg/kg
AlbendazoleDRUGAlbendazole 7 days
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with positive strongyloides larva in the stool Exclusion Criteria: * Pregnancy * Lactating women * Known allergy to any study drug

Countries:Thailand
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