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Home > "S" Clinical Trials Conditions > Study of FK463 for the Treatment of Invasive Aspergillosis  Study of FK463 for the Treatment of Invasive Aspergillosis
Study of FK463 for the Treatment of Invasive Aspergillosis
For Condition: Aspergillosis
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. , Fujisawa GmbH
Synopsis: 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.
Details: This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 100
Location and Contact Information:
Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
Madrid, , ES 28007
Spain
Christie Hospital NHS Trust
Manchester, , M20 4BX
United Kingdom
Johann Wolfgang Goethe Universitat, Medizinische Klinik III
Frankfurt, , D-60590
Germany
Hopital Necker Enfants Malades, Service d'Hematologie
Paris, , 75015
France
Royal Free Hospital, Dept. of Haematological Oncology
London, , NW3 2QG
United Kingdom
Medizinische Univ.-Klinik
Graz, , 8036
Austria
Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
Leipzig, , D-04103
Germany
Klinikum der Stadt, Medizinische Klinik A
Ludwigshafen, , D-67063
Germany
Krankenhaus Elisabethinen Linz
Linz, , A-4010
Austria
Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
Paris, , 10
France
Hopital Henri Mondor, Service d'Hematologie Clinique
Creteil, , 94010
France
Hotel Dieu, Service d'Hematologie
Nantes, , 44093
France
Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
Milano, , 20162
Italy
LMU Munchen, Hamatopoetische Zell - Transplantation
Munchen, , D-81366
Germany
Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
Wurzburg, , E-97070
Germany
Nationale Institute for Cancer Research
Genova, , I 16132
Italy
Institute of Haematology and Blood Transfusion
Warsaw, , 00-957
Poland
Hospital Clinic I provencial, Servicio Enfermadades Infecciosas
Barcelona, , ES 28041
Spain
Westpfalz Krankehaus
Kaiserslautern, , D-67655
Germany
Royal Marsden Hospital
Sutton Surrey, , SM2 5PT
United Kingdom
Uniklinik Mainz
Mainz, , 55101
Germany
Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas
Madrid, , ES 28041
Spain
Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
Huddinge, , SE141 86
Sweden
Additional Information:
Study ID Numbers: 98-0-046 (FG463-21-01);
Study Start Date: January 1999
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036166
Other Aspergillosis Studies:
1. Voriconazole to Prevent Systemic Fungal Infections in Children
2. Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis
3. Trial of Micafungin (FK463) in Combination with Liposomal Amphotericin B (AmBisome) for Aspergillosis
4. A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
5. An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Related Studies:
Other Aspergillosis Clinical Trials
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Study of FK463 for the Treatment of Invasive Aspergillosis
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