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| 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 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and 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 | |
More Information
| 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 |
