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AmBisome

Phase 3

Invasive Aspergillosis | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Nov 18, 2005

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00158730Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial TreatmentPHASE3 COMPLETED 800Apr 1, 2003Jan 1, 2005Nov 18, 2005 -
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Study Endpoints
Primary Endpoints
Evaluate two regimens determined by overall response rates at end of tx.
Secondary Endpoints
Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
AmBisomeDRUG -
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Eligibility Criteria
Age Range1 Month — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less th...

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