Recent Updates
Recently added Catalysts

AmBisome

Phase 4

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

AmBisome development status

Highest phase Phase 4 (NCT00362544)
Phase scored for GILDPhase 3
Registered trials 15 across 7 sponsors since Aug 2001

AmBisome target and mechanism

ModalitySmall molecule

Also known as Liposomal amphotericin B, Liposomal amphotericin B (AmBisome®)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment834

FDA Designations

No designations recorded

AmBisome clinical trials

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
Unlock trial analytics

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
AmBisomeDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about AmBisome

What is AmBisome used for?

AmBisome is an antifungal drug being studied for the treatment of invasive aspergillosis and other fungal infections. It is also being investigated as a prophylactic treatment for fungus diseases in high-risk patients undergoing allogeneic stem cell transplantation. The drug is in clinical development by Gilead Sciences.

Who makes AmBisome?

AmBisome is developed by Gilead Sciences, Inc., which trades under the ticker GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating fungal infections, including invasive aspergillosis.

What phase is AmBisome in?

AmBisome is in Phase 2 clinical development. One completed Phase 2 trial evaluated its use as antifungal prophylaxis in high-risk stem cell transplant patients. A separate completed Phase 3 trial studied loading dose regimens for initial treatment of invasive aspergillosis and other fungal infections.

What clinical trials is AmBisome in?

AmBisome has been studied in two completed clinical trials. NCT00158730 was a Phase 3 study of 800 patients comparing a loading dose regimen to a standard regimen for invasive aspergillosis and other fungal infections. NCT00326157 was a Phase 2 study of 34 patients in Italy evaluating prophylaxis in stem cell transplant recipients.

Is AmBisome FDA approved?

AmBisome is an investigational drug still in clinical development. It has not been reported as FDA approved. The available data shows completed clinical trials, but no approval status has been indicated.

Explore more on BiopharmaWatch

Gilead Sciences, Inc. (GILD)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with ACompanies A to ZEvery biotech and pharma company we track