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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Primary Purpose

Candidiasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FK463
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Candidemia, Anti-Fungal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Univ.-Klinik
  • Krankenhaus Elisabethinen Linz
  • Hopital Henri Mondor, Dervice d'Hematologie Clinique
  • Hotel Dieu, Service d"Hematologie
  • Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
  • Hopital Necker Enfants Malades, Service d"Hematologie
  • Johann Wolfgang Goethe Universitat, Medizinische Klinik III
  • Westpfalz Krankenhaus
  • Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
  • Klinikum der Stadt, Medizinische Klinik A
  • Uniklinik Mainz, III. Medizinische Klinik
  • LMU Munchen, Hamatopoetische Zell - Transplantation
  • Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
  • Nationale Institute for Cancer Research
  • Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
  • Institute of Haematology and Blood Transfusion
  • Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
  • Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
  • Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
  • Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
  • Royal Free Hospital, Dept. of Haematological Oncology
  • Christie Hospital NHS Trust
  • Royal Marsden Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
January 8, 2018
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00036179
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 27, 1999 (Actual)
Primary Completion Date
January 27, 2002 (Actual)
Study Completion Date
January 27, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

5. 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.
Detailed Description
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
Keywords
Candidemia, Anti-Fungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FK463

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medizinische Univ.-Klinik
City
Graz
ZIP/Postal Code
A 8036
Country
Austria
Facility Name
Krankenhaus Elisabethinen Linz
City
Linz
ZIP/Postal Code
A-4010
Country
Austria
Facility Name
Hopital Henri Mondor, Dervice d'Hematologie Clinique
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hotel Dieu, Service d"Hematologie
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
City
Paris
ZIP/Postal Code
10
Country
France
Facility Name
Hopital Necker Enfants Malades, Service d"Hematologie
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Westpfalz Krankenhaus
City
Kaiserslautern
ZIP/Postal Code
D-67655
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Klinikum der Stadt, Medizinische Klinik A
City
Ludwigshafen
ZIP/Postal Code
D-67063
Country
Germany
Facility Name
Uniklinik Mainz, III. Medizinische Klinik
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
LMU Munchen, Hamatopoetische Zell - Transplantation
City
Munchen
ZIP/Postal Code
D-81366
Country
Germany
Facility Name
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
City
Wurzburg
ZIP/Postal Code
D-97070
Country
Germany
Facility Name
Nationale Institute for Cancer Research
City
Genova
ZIP/Postal Code
I 16132
Country
Italy
Facility Name
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Institute of Haematology and Blood Transfusion
City
Warsaw
ZIP/Postal Code
00-957
Country
Poland
Facility Name
Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas
City
Barcelona
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
City
Madrid
ZIP/Postal Code
ES 28007
Country
Spain
Facility Name
Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas
City
Madrid
ZIP/Postal Code
ES 28041
Country
Spain
Facility Name
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
City
Huddinge
ZIP/Postal Code
SE141 86
Country
Sweden
Facility Name
Royal Free Hospital, Dept. of Haematological Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=60
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

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