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NCT00036166 Clinical Trial

Study of FK463 for the Treatment of Invasive Aspergillosis

Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036166
Other study ID # FG463-21-01
Secondary ID 98-0-046
Status Completed
Phase Phase 2
First received May 8, 2002
Last updated January 8, 2018
Start date January 29, 1999
Est. completion date January 31, 2002

Study information
Verified date June 2015
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 326
Est. completion date January 31, 2002
Est. primary completion date January 31, 2002
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• FK463

Locations
Country Name City State
Austria Medizinische Univ.-Klinik Graz
Austria Krankenhaus Elisabethinen Linz Linz
France Hopital Henri Mondor, Service d'Hematologie Clinique Creteil
France Hotel Dieu, Service d'Hematologie Nantes
France Hopital Necker Enfants Malades, Service d'Hematologie Paris
France Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle Paris
Germany Johann Wolfgang Goethe Universitat, Medizinische Klinik III Frankfurt
Germany Westpfalz Krankehaus Kaiserslautern
Germany Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie Leipzig
Germany Klinikum der Stadt, Medizinische Klinik A Ludwigshafen
Germany Uniklinik Mainz Mainz
Germany LMU Munchen, Hamatopoetische Zell - Transplantation Munchen
Germany Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie Wurzburg
Italy Nationale Institute for Cancer Research Genova
Italy Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera Milano
Poland Institute of Haematology and Blood Transfusion Warsaw
Spain Hospital Clinic I provencial, Servicio Enfermadades Infecciosas Barcelona
Spain Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas Madrid
Spain Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas Madrid
Sweden Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology Huddinge
United Kingdom Royal Free Hospital, Dept. of Haematological Oncology London
United Kingdom Christie Hospital NHS Trust Manchester
United Kingdom Royal Marsden Hospital Sutton Surrey

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute inv — View Citation

Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdière M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem ce — View Citation

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