Study of FK463 for the Treatment of Invasive Aspergillosis

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: NCT00036166
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 patients with proven or probable invasive infections due to Aspergillus species.

Condition or disease Intervention/treatment Phase
Aspergillosis 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 : 326 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 for the Treatment of Invasive Aspergillosis
Actual Study Start Date : January 29, 1999
Primary Completion Date : January 31, 2002
Study Completion Date : January 31, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Information from the National Library of Medicine

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

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

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): NCT00036166

Medizinische Univ.-Klinik
Graz, Austria, 8036
Krankenhaus Elisabethinen Linz
Linz, Austria, A-4010
Hopital Henri Mondor, Service 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 Krankehaus
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
Mainz, Germany, 55101
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, Germany, D-81366
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, Germany, E-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, ES 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:
Publications of Results:
Responsible Party: Astellas Pharma Inc Identifier: NCT00036166     History of Changes
Other Study ID Numbers: FG463-21-01
98-0-046 ( Other Identifier: Alternate Protocol Number )
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:
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents