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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 18, 2002

Last Updated Date

September 29, 2008

Start Date ^†

December 2002

Current Primary Outcome Measures ^†

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 ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

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 ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Condition ^†

Aspergillosis

Intervention ^†

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 ^†

Terminated

Enrollment ^†

Completion Date

February 2003

Primary Completion Date

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

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00047827

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc

Secondary IDs ^††

FG463-21-11

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.