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Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

NCT ID: NCT00036179

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-27

Study Completion Date

2002-01-27

Brief Summary

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The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

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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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Candidiasis

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 Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has life expectancy judged to be less than 5 days
* De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =\< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
* Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis
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, Dervice 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 Krankenhaus

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, III. Medizinische Klinik

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

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=60

Link to results on Astellas Clinical Study Results website

Other Identifiers

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98-0-047

Identifier Type: -

Identifier Source: secondary_id

FG463-21-02

Identifier Type: -

Identifier Source: org_study_id

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