Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis - Tabular View

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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

This study has been completed.

Study NCT00036179. Last updated on July 9, 2008. Information provided by Astellas Pharma Inc

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Official Title ^†	An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Brief Summary	The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.
Detailed Description	This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Candidiasis
Intervention ^†	Drug: FK463
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	75
Start Date ^†	February 1999
Completion Date	December 2002
Eligibility Criteria ^†	Inclusion Criteria Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation Exclusion Criteria Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal Has life expectancy judged to be less than 5 days De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Administrative Information Fields
NCT ID ^†	NCT00036179
Organization ID	FG463-21-02
Secondary IDs ^††	98-0-047
Study Sponsor ^†	Astellas Pharma Inc
Collaborators ^††
Investigators ^†
Information Provided By	Astellas Pharma Inc
Verification Date	July 2008
First Received Date ^†	May 8, 2002
Last Updated Date	July 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.