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

This study has been terminated.

( Inadequate enrollment )

First Received: October 18, 2002 Last Updated: September 29, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00047827

Purpose

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.

Condition	Intervention	Phase
Aspergillosis	Drug: Micafungin Drug: Liposomal Amphotericin B	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: FK 463 Micafungin Amphotericin B

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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 ]

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 ]

Enrollment:	2
Study Start Date:	December 2002
Study Completion Date:	February 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Micafungin IV Drug: Liposomal Amphotericin B IV

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047827

Locations

United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Georgia

Atlanta, Georgia, United States, 30322
United States, Michigan

Detroit, Michigan, United States, 48201

Ann Arbor, Michigan, United States, 48109
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Tennessee

Memphis, Tennessee, United States, 38105
United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma US, Inc ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	01-0-125, FG463-21-11
Study First Received:	October 18, 2002
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00047827 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Aspergillus
Aspergillosis
Anti-Fungal
AmBisome
Micafungin

Additional relevant MeSH terms:

Abelcet
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Aspergillosis
Liposomal amphotericin B
Pharmacologic Actions
Micafungin

Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on November 27, 2009