Study of FK463 for the Treatment of Invasive Aspergillosis - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00036166

Purpose

The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

Condition	Intervention	Phase
Aspergillosis	Drug: FK463	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

Resource links provided by NLM:

Drug Information available for: FK 463 Micafungin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Enrollment:	326
Study Start Date:	January 1999
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Has proven or probable systemic infection with Aspergillus species

Exclusion Criteria

Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
Has life-expectancy judged to be less than 5 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036166

Locations

Austria
Medizinische Univ.-Klinik
Graz, Austria, 8036
Krankenhaus Elisabethinen Linz
Linz, Austria, A-4010
France
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, France, 10
Hopital Henri Mondor, Service d'Hematologie Clinique
Creteil, France, 94010
Hopital Necker Enfants Malades, Service d'Hematologie
Paris, France, 75015
Hotel Dieu, Service d'Hematologie
Nantes, France, 44093
Germany
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, Germany, E-97070
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, Germany, D-81366
Westpfalz Krankehaus
Kaiserslautern, Germany, D-67655
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, Germany, D-04103
Uniklinik Mainz
Mainz, Germany, 55101
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, Germany, D-67063
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, Germany, D-60590
Italy
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milano, Italy, 20162
Nationale Institute for Cancer Research
Genova, Italy, I 16132
Poland
Institute of Haematology and Blood Transfusion
Warsaw, Poland, 00-957
Spain
Hospital Clinic I provencial, Servicio Enfermadades Infecciosas
Barcelona, Spain, ES 28041
Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas
Madrid, Spain, ES 28041
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, Spain, ES 28007
Sweden
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

More Information

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG463-21-01, 98-0-046
Study First Received:	May 8, 2002
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00036166 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Aspergillus
Anti-Fungal

Study placed in the following topic categories:

Mycoses
Antifungal Agents
Aspergillosis
Micafungin

Additional relevant MeSH terms:

Anti-Infective Agents
Mycoses
Therapeutic Uses
Antifungal Agents

Aspergillosis
Pharmacologic Actions
Micafungin

ClinicalTrials.gov processed this record on July 02, 2009