Study of FK463 for the Treatment of Invasive Aspergillosis

Condition(s) targeted: Aspergillosis

Intervention: FK463 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Inc

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.

Official title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Detailed description: This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Medizinische Univ.-Klinik, Graz 8036, Austria

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

Hopital Necker Enfants Malades, Service d'Hematologie, Paris 75015, France

Hotel Dieu, Service d'Hematologie, Nantes 44093, France

Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie, Wurzburg E-97070, Germany

LMU Munchen, Hamatopoetische Zell - Transplantation, Munchen D-81366, Germany

Westpfalz Krankehaus, Kaiserslautern D-67655, Germany

Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie, Leipzig D-04103, Germany

Uniklinik Mainz, Mainz 55101, Germany

Klinikum der Stadt, Medizinische Klinik A, Ludwigshafen D-67063, Germany

Johann Wolfgang Goethe Universitat, Medizinische Klinik III, Frankfurt D-60590, Germany

Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera, Milano 20162, Italy

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

Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas, Madrid ES 28041, Spain

Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas, Madrid ES 28007, Spain

Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology, Huddinge SE141 86, Sweden

Royal Free Hospital, Dept. of Haematological Oncology, London NW3 2QG, United Kingdom

Christie Hospital NHS Trust, Manchester M20 4BX, United Kingdom

Royal Marsden Hospital, Sutton Surrey SM2 5PT, United Kingdom

Click here for more information about the sponsor: Fujisawa Healthcare, Inc.

Click here for more information about the sponsor's affiliate: Fujisawa-GmbH

Starting date: January 1999
Ending date: December 2002
Last updated: March 12, 2008