Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

September 29, 2008

Start Date ^ICMJE

December 2002

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of treatment response defined as complete or partial response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00047827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Radiological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Mycological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
Survival at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

Official Title ^ICMJE

A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Aspergillosis

Intervention ^ICMJE

Drug: Micafungin
Drug: Liposomal Amphotericin B

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy

Exclusion Criteria

Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
Has life expectancy of less than five days

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00047827

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc

Study ID Numbers ^ICMJE

01-0-125, FG463-21-11

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP