Study of FK463 for the Treatment of Invasive Aspergillosis

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00036166

Collaborator

(none)

326

Enrollment

Locations

36.1

Actual Duration (Months)

14.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspergillosis	Drug: FK463	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

326 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 29, 1999

Actual Primary Completion Date :

Jan 31, 2002

Actual Study Completion Date :

Jan 31, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

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