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| Sponsored by: |
Astellas Pharma Inc |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00036179 |
Purpose
The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.
| Condition | Intervention | Phase |
|
Candidiasis |
Drug: FK463 |
Phase II |
| MedlinePlus related topics: | Yeast Infections |
| Drug Information available for: | Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463 |
| 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 in the Treatment of Candidemia or Invasive Candidiasis |
| Enrollment: | 75 |
| Study Start Date: | February 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, A 8036 | |||||
| Krankenhaus Elisabethinen Linz | |||||
| Linz, Austria, A-4010 | |||||
| France | |||||
| Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle | |||||
| Paris, France, 10 | |||||
| Hopital Henri Mondor, Dervice 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, D-97070 | |||||
| LMU Munchen, Hamatopoetische Zell - Transplantation | |||||
| Munchen, Germany, D-81366 | |||||
| Westpfalz Krankenhaus | |||||
| Kaiserslautern, Germany, D-67655 | |||||
| Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie | |||||
| Leipzig, Germany, D-04103 | |||||
| Uniklinik Mainz, III. Medizinische Klinik | |||||
| 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, 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 | |||||
| Astellas Pharma Inc |
More Information
| Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
| Study ID Numbers: | FG463-21-02, 98-0-047 |
| First Received: | May 8, 2002 |
| Last Updated: | July 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00036179 |
| Health Authority: | United States: Food and Drug Administration |
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