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. Identifier: NCT00036179
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : January 10, 2018
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.

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
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT00036179

Medizinische Univ.-Klinik
Graz, Austria, A 8036
Krankenhaus Elisabethinen Linz
Linz, Austria, A-4010
Hopital Henri Mondor, Dervice d'Hematologie Clinique
Creteil, France, 94010
Hotel Dieu, Service d"Hematologie
Nantes, France, 44093
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, France, 10
Hopital Necker Enfants Malades, Service d"Hematologie
Paris, France, 75015
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, Germany, D-60590
Westpfalz Krankenhaus
Kaiserslautern, Germany, D-67655
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, Germany, D-04103
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, Germany, D-67063
Uniklinik Mainz, III. Medizinische Klinik
Mainz, Germany, 55101
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, Germany, D-81366
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, Germany, D-97070
Nationale Institute for Cancer Research
Genova, Italy, I 16132
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milano, Italy, 20162
Institute of Haematology and Blood Transfusion
Warsaw, Poland, 00-957
Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
Barcelona, Spain, 28041
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, Spain, ES 28007
Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
Madrid, Spain, ES 28041
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
Huddinge, Sweden, SE141 86
United Kingdom
Royal Free Hospital, Dept. of Haematological Oncology
London, United Kingdom, NW3 2QG
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital
Sutton Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00036179     History of Changes
Other Study ID Numbers: FG463-21-02
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Antifungal Agents
Anti-Infective Agents