A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).
Information source: Pfizer
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspergillosis
Intervention: Anidulafungin, VER002 (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
Official title: An Open Label Non-Comparative Study of the Safety and Efficacy of Intravenous Anidulafungin Plus AmBisome® [(Amphotericin B) Liposome for Injection] as a Treatment for Invasive Aspergillosis.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of definite IA outside the pulmonary system or definite or probable
pulmonary IA
- Life expectancy: greater than 72 hours
Exclusion Criteria:
- Pregnant female
- Hypersensitivity to anidulafungin or echinocandin therapy
- Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
- Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome
unless, in the opinion of the investigator, the benefit of therapy outweighs the
risk.
- Aspergilloma-in the absence of invasive disease
- Abnormal blood chemistries:
Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT
(alanine aminotransferase)> 5 times the upper limit of normal
- Greater than five days of therapeutic doses of systemic therapy for the current
Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of
amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than
2g of itraconazole for the current condition. Prophylactic use of azoles or
amphotericin is acceptable.
- Less than 4 weeks since prior participation in an investigational drug or device
study, with the exception of cytotoxic, antiretroviral agents and therapies for
AIDS-related opportunistic infections.
Locations and Contacts
Versicor, Inc., King of Prussia, Pennsylvania 19406, United States
Additional Information
Link to ClinicalStudyResults.org Posting’
Starting date: May 2002
Ending date: February 2003
Last updated: April 26, 2007
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