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

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	July 9, 2008
Start Date ^ICMJE	February 1999
Primary Completion Date	December 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Candidiasis
Intervention ^ICMJE	Drug: FK463
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	75
Completion Date	December 2002
Primary Completion Date	December 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00036179
Responsible Party	Disclosure Office Europe, Astellas Pharma Europe BV
Study ID Numbers ^ICMJE	FG463-21-02, 98-0-047
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Astellas Pharma Inc
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP