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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00036179
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Candidiasis Drug: FK463 Phase 2

Detailed Description:
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis
Actual Study Start Date : February 27, 1999
Actual Primary Completion Date : January 27, 2002
Actual Study Completion Date : January 27, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036179


Locations
Show Show 23 study locations
Sponsors and Collaborators
Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00036179    
Other Study ID Numbers: FG463-21-02
98-0-047
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: June 2015
Keywords provided by Astellas Pharma Inc:
Candidemia
Anti-Fungal
Additional relevant MeSH terms:
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Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Micafungin
Antifungal Agents
Anti-Infective Agents