Micafungin and FK463 in Candidiasis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Candidiasis

Intervention / Treatment

Drug: FK463

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

Enrollment (Actual)

75

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Link to results on Astellas Clinical Study Results website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 1999

Primary Completion (Actual)

January 27, 2002

Study Completion (Actual)

January 27, 2002

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 8, 2002

First Posted (Estimate)

May 9, 2002

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

FG463-21-02
98-0-047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis