MedPath

Study of FK463 for the Treatment of Invasive Aspergillosis

Phase 2
Completed
Conditions
Aspergillosis
Registration Number
NCT00036166
Lead Sponsor
Astellas Pharma Inc
Brief 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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
326
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (23)

Hopital Henri Mondor, Service d'Hematologie Clinique

🇫🇷

Creteil, France

Hotel Dieu, Service d'Hematologie

🇫🇷

Nantes, France

Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

🇫🇷

Paris, France

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

LMU Munchen, Hamatopoetische Zell - Transplantation

🇩🇪

Munchen, Germany

Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

🇩🇪

Wurzburg, Germany

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

🇮🇹

Milano, Italy

Hospital Clinic I provencial, Servicio Enfermadades Infecciosas

🇪🇸

Barcelona, Spain

Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

🇪🇸

Madrid, Spain

Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas

🇪🇸

Madrid, Spain

Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

🇸🇪

Huddinge, Sweden

Royal Free Hospital, Dept. of Haematological Oncology

🇬🇧

London, United Kingdom

Christie Hospital NHS Trust

🇬🇧

Manchester, United Kingdom

Royal Marsden Hospital

🇬🇧

Sutton Surrey, United Kingdom

Krankenhaus Elisabethinen Linz

🇦🇹

Linz, Austria

Institute of Haematology and Blood Transfusion

🇵🇱

Warsaw, Poland

Medizinische Univ.-Klinik

🇦🇹

Graz, Austria

Nationale Institute for Cancer Research

🇮🇹

Genova, Italy

Hopital Necker Enfants Malades, Service d'Hematologie

🇫🇷

Paris, France

Uniklinik Mainz

🇩🇪

Mainz, Germany

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