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AmBisome

Phase 3

Invasive Aspergillosis | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Feb 12, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

AmBisome · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00158730Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial TreatmentInvasive Aspergillosis
COMPLETED800 Analytics
PHASE3COMPLETED
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
Invasive Aspergillosis
NCT00158730800
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Study Endpoints

Primary Endpoints

Evaluate two regimens determined by overall response rates at end of tx.
Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
Through 16 weeks
Number (%) of patients with infusion related AE
Through 16 weeks
Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)
Through 16 weeks
Overall adverse events
Through 16 weeks

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
Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment
Within previous 6 months
Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment
Within previous 6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAmBisome® will be administered for a duration of 8 weeks

Interventions

NameTypeDescription
AmBisomeDRUG -
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Eligibility Criteria

Age Range1 Month to 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...

Countries:Italy
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Frequently asked questions about AmBisome

What is AmBisome used for?

AmBisome is used for the treatment of invasive aspergillosis and other fungal diseases. It is being studied for these infectious disease indications, with clinical trials evaluating its safety and efficacy in patients with invasive aspergillosis and other fungal infections.

Who makes AmBisome?

AmBisome is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is responsible for the clinical development and commercialization of this antifungal drug.

What does AmBisome target?

AmBisome is a small molecule antifungal agent. It works by binding to ergosterol, a key component of fungal cell membranes, which disrupts the membrane and leads to fungal cell death. This mechanism makes it effective against invasive aspergillosis and other fungal pathogens.

What phase is AmBisome in?

AmBisome is in Phase 2 clinical development. While one completed trial was Phase 3, the most recent trial, NCT00326157, is Phase 2. AmBisome is investigational and still in clinical development, not yet approved for the studied indications.

What clinical trials is AmBisome in?

AmBisome has been studied in two completed trials. NCT00158730 was a Phase 3 study comparing a loading dose regimen to a standard regimen for initial treatment of invasive aspergillosis and other fungal infections, enrolling 800 patients. NCT00326157 was a Phase 2 study in Italy evaluating AmBisome as antifungal prophylaxis in high-risk patients undergoing allogeneic stem cell transplantation, enrolling 34 patients.

Is AmBisome the same as amphotericin B?

AmBisome is a lipid formulation of amphotericin B, a polyene antifungal. It is designed to reduce the toxicity of conventional amphotericin B while maintaining efficacy. The drug name AmBisome specifically refers to this liposomal formulation developed by Gilead Sciences.