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Thymoglobulin

Phase 2

Liver Dysfunction | Monoclonal antibody | Gastrointestinal |Sanofi|Last Updated: Mar 18, 2015

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 Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00117689Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant RejectionPHASE2 COMPLETED 75Apr 1, 2005Dec 1, 2007Mar 18, 201516 United States, Canada
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Study Endpoints
Primary Endpoints
Freedom from biopsy-proven acute rejection (including humoral rejection)
6 months
Secondary Endpoints
Explore the impact of Thymoglobulin on kidney function after transplant
6 months
Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALStandard (tacrolimus based standard therapy without induction)
2 Standard of CareACTIVE_COMPARATORThymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy
Interventions
NameTypeDescription
ThymoglobulinBIOLOGICALAntibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
CorticosteroidDRUGFor a minimum of 3 months
TacrolimusDRUGBetween Day 3 the last dose of Thymoglobulin
Mycophenolate MofetilDRUGfor at least 1 month posttransplant
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation * Serum creatinine \> 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation * Ages greate...

Countries:United StatesCanada
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