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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00036166 |
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 |
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) |
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
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 |
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 |
Health Authority: | United States: Food and Drug Administration |
Aspergillus Anti-Fungal |
Mycoses Clotrimazole Miconazole |
Tioconazole Aspergillosis Micafungin |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |