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Neoral

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Novartis AG|Last Updated: Sep 22, 2014

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00286871Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing RegimenPHASE1 COMPLETED 40 — — Feb 1, 2006Feb 1, 2009Sep 22, 20141 United States
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Study Endpoints
Primary Endpoints
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
Secondary Endpoints
compare the effectiveness of Neoral with Prograf as primary immunotherapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
NeoralDRUG -
TacrolimusDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * adult patients who have received liver transplant Exclusion Criteria: * pregnant women * nursing women

Countries:United States
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