Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00036179
Collaborator
(none)
75
23
35
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Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Feb 27, 1999
Actual Primary Completion Date :
Jan 27, 2002
Actual Study Completion Date :
Jan 27, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00036179
    Other Study ID Numbers:
    • FG463-21-02
    • 98-0-047
    First Posted:
    May 9, 2002
    Last Update Posted:
    Jan 10, 2018
    Last Verified:
    Jun 1, 2015
    Keywords provided by Astellas Pharma Inc
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 10, 2018