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Sargramostim

Phase 1

HIV Infections | Small molecule | Infectious Disease |Novartis AG|Last Updated: Jun 24, 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
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002008An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and LeukopeniaPHASE1 COMPLETED - - -Jun 24, 20052 United States
NCT00002009A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and LeukopeniaPHASE1 COMPLETED - - -Jun 24, 20052 United States
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Study Design & Arms
MaskingNONE
PurposeTREATMENT
Interventions
NameTypeDescription
SargramostimDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Patients must have: * Serum antibody to HIV with or without evidence of HIV. * Antigenemia. * Anticipated survival of at least 6 months. * Allowed: * Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: ...

Countries:United States
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