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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR AMBISOME

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505(b)(2) Clinical Trials for Ambisome

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT00421187 Ambisome and Management of Culture-negative Neutropenic Fever Unresponsive to Antibiotics Terminated Gilead Sciences Phase 4 2007-03-01 Administration of a single high dose (10 mg/kg) of AmBisome® no later than 72 hours after ARNF onset followed by two 5 mg/kg doses on days 2 and 5 may provide sustained tissue levels of amphotericin B that are as mycologically effective as those provided after administering the standard daily dose of 3 mg/kg/day. The new dosing regimen is anticipated to be equally clinically effective compared with the standard AmBisome® regimen when given for the duration of neutropenic fever in patients with ARNF. In addition, the degree and incidence of nephrotoxicity are predicted to be lower with the 3 sequential dose regimen compared to daily dosing with 3 mg/kg because of the lower cumulative dosage (20 mg/kg versus 42 mg/kg, respectively), which is 1 contributing factor for the development of acute renal failure. Furthermore, the lower cumulative dose may be a cost-effective strategy for the treatment of patients with ARNF.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ambisome

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001107 Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 4 1969-12-31 The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication. IFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.
NCT00003938 Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1999-06-01 RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.
NCT00037206 A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). Completed Vicuron Pharmaceuticals Phase 2/Phase 3 2002-05-01 The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.
NCT00037206 A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA). Completed Pfizer Phase 2/Phase 3 2002-05-01 The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.
NCT00047827 Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis Terminated Astellas Pharma Inc Phase 2 2002-12-01 The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ambisome

Condition Name

Condition Name for Ambisome
Intervention Trials
Visceral Leishmaniasis 11
Aspergillosis 3
Leishmaniasis 3
Leishmaniasis, Visceral 2
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Condition MeSH

Condition MeSH for Ambisome
Intervention Trials
Leishmaniasis 22
Leishmaniasis, Visceral 18
Mycoses 10
Aspergillosis 9
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Clinical Trial Locations for Ambisome

Trials by Country

Trials by Country for Ambisome
Location Trials
United States 38
Canada 9
France 9
India 9
Spain 7
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Trials by US State

Trials by US State for Ambisome
Location Trials
Texas 5
Pennsylvania 4
District of Columbia 4
Florida 2
California 2
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Clinical Trial Progress for Ambisome

Clinical Trial Phase

Clinical Trial Phase for Ambisome
Clinical Trial Phase Trials
Phase 4 14
Phase 3 16
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ambisome
Clinical Trial Phase Trials
Completed 32
Terminated 7
Recruiting 4
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Clinical Trial Sponsors for Ambisome

Sponsor Name

Sponsor Name for Ambisome
Sponsor Trials
Gilead Sciences 13
Drugs for Neglected Diseases 10
Banaras Hindu University 5
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Sponsor Type

Sponsor Type for Ambisome
Sponsor Trials
Other 60
Industry 27
U.S. Fed 4
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