Recent Updates
Recently added Catalysts

nebulised liposomal amphotericin B

Phase 2

Aspergillosis | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Aug 18, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment320
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00263315Inhalation of Liposomal Amphotericin B to Prevent Invasive AspergillosisPHASE2 COMPLETED 320Jan 1, 2000May 1, 2006Aug 18, 20062 Netherlands
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
SAFETY: Discontinuation for >1week due to intolerance
EFFICACY: Proven/probable invasive pulmonary aspergillosis
Secondary Endpoints
SAFETY STUDY:
A probably or definitely related AE of the respiratory tract (CTC grade > 2)
Any probably or definitely related AE by type and severity (CTC grade > 2)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
nebulised liposomal amphotericin BDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female hospitalized patients aged \> 18 yr 2. The patient has a hematologic malignancy or will receive a bone-marrow transplant 3. The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission 4. The expected duration of severe ...

Countries:Netherlands
Unlock Eligibility Criteria