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caspofungin

Phase 2

Hematopoietic Stem Cell Transplantation | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Jan 16, 2008

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00148148A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell TransplantationPHASE2 COMPLETED 75 — — May 1, 2004Dec 1, 2007Jan 16, 20081 Germany
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Study Endpoints
Primary Endpoints
Safety and efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin with liposomal amphotericin B in accordance with NCI-CTC toxicity
Secondary Endpoints
Pharmacokinetics and recording of the dose-intensity of caspofungin and liposomal amphotericin B in the setting of allogeneic stem cell transplantation
Examination of pharmacokinetical interactions between caspofungin and liposomal amphotericin B
Recording of the efficacy of caspofungin, liposomal amphotericin B and the combination of caspofungin and liposomal amphotericin B in the case of empirical antimycotic therapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
caspofunginDRUG -
liposomal amphotericin BDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adults (\> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes \[ANC\]: \< or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A * Patients with persistent or recurrent f...

Countries:Germany
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