Study of FK463 for the Treatment of Invasive Aspergillosis

January 8, 2018 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Univ.-Klinik
      • Linz, Austria, A-4010
        • Krankenhaus Elisabethinen Linz
  • France
      • Creteil, France, 94010
        • Hopital Henri Mondor, Service d'Hematologie Clinique
      • Nantes, France, 44093
        • Hotel Dieu, Service d'Hematologie
      • Paris, France, 10
        • Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle
      • Paris, France, 75015
        • Hopital Necker Enfants Malades, Service d'Hematologie
  • Germany
      • Frankfurt, Germany, D-60590
        • Johann Wolfgang Goethe Universitat, Medizinische Klinik III
      • Kaiserslautern, Germany, D-67655
        • Westpfalz Krankehaus
      • Leipzig, Germany, D-04103
        • Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie
      • Ludwigshafen, Germany, D-67063
        • Klinikum der Stadt, Medizinische Klinik A
      • Mainz, Germany, 55101
        • Uniklinik Mainz
      • Munchen, Germany, D-81366
        • LMU Munchen, Hamatopoetische Zell - Transplantation
      • Wurzburg, Germany, E-97070
        • Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie
  • Italy
      • Genova, Italy, I 16132
        • Nationale Institute for Cancer Research
      • Milano, Italy, 20162
        • Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera
  • Poland
      • Warsaw, Poland, 00-957
        • Institute of Haematology and Blood Transfusion
  • Spain
      • Barcelona, Spain, ES 28041
        • Hospital Clinic I provencial, Servicio Enfermadades Infecciosas
      • Madrid, Spain, ES 28007
        • Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas
      • Madrid, Spain, ES 28041
        • Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas
  • Sweden
      • Huddinge, Sweden, SE141 86
        • Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital, Dept. of Haematological Oncology
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
      • Sutton Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 1999

Primary Completion (Actual)

January 31, 2002

Study Completion (Actual)

January 31, 2002

Study Registration Dates

First Submitted

May 8, 2002

First Submitted That Met QC Criteria

May 8, 2002

First Posted (Estimate)

May 9, 2002

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG463-21-01
  • 98-0-046 (Other Identifier: Alternate Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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