Study of FK463 for the Treatment of Invasive Aspergillosis

NCT ID: NCT00036166

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-29

Study Completion Date

2002-01-31

Brief Summary

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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

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

Conditions

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Aspergillosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FK463

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Univ.-Klinik

Graz, , Austria

Site Status

Krankenhaus Elisabethinen Linz

Linz, , Austria

Site Status

Hopital Henri Mondor, Service d'Hematologie Clinique

Créteil, , France

Site Status

Hotel Dieu, Service d'Hematologie

Nantes, , France

Site Status

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

Paris, , France

Site Status

Hopital Necker Enfants Malades, Service d'Hematologie

Paris, , France

Site Status

Johann Wolfgang Goethe Universitat, Medizinische Klinik III

Frankfurt, , Germany

Site Status

Westpfalz Krankehaus

Kaiserslautern, , Germany

Site Status

Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie

Leipzig, , Germany

Site Status

Klinikum der Stadt, Medizinische Klinik A

Ludwigshafen, , Germany

Site Status

Uniklinik Mainz

Mainz, , Germany

Site Status

LMU Munchen, Hamatopoetische Zell - Transplantation

München, , Germany

Site Status

Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

Würzburg, , Germany

Site Status

Nationale Institute for Cancer Research

Genova, , Italy

Site Status

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

Milan, , Italy

Site Status

Institute of Haematology and Blood Transfusion

Warsaw, , Poland

Site Status

Hospital Clinic I provencial, Servicio Enfermadades Infecciosas

Barcelona, , Spain

Site Status

Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

Madrid, , Spain

Site Status

Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas

Madrid, , Spain

Site Status

Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

Huddinge, , Sweden

Site Status

Royal Free Hospital, Dept. of Haematological Oncology

London, , United Kingdom

Site Status

Christie Hospital NHS Trust

Manchester, , United Kingdom

Site Status

Royal Marsden Hospital

Sutton Surrey, , United Kingdom

Site Status

Countries

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Austria France Germany Italy Poland Spain Sweden United Kingdom

References

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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 invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6.

Reference Type RESULT
PMID: 16678903 (View on PubMed)

Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere 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 cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.

Reference Type RESULT
PMID: 18983417 (View on PubMed)

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=59

Link to results on Astellas Clinical Study Results website

Other Identifiers

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98-0-046

Identifier Type: OTHER

Identifier Source: secondary_id

FG463-21-01

Identifier Type: -

Identifier Source: org_study_id

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