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

August 19, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48201
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Drug: Liposomal Amphotericin B
IV
Other Names:
  • AmBisome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment response defined as complete or partial response
Time Frame: Day 28, end of combined therapy and Day 84
Day 28, end of combined therapy and Day 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Response
Time Frame: Day 28, end of combined therapy and Day 84
Day 28, end of combined therapy and Day 84
Radiological Response
Time Frame: Day 28, end of combined therapy and Day 84
Day 28, end of combined therapy and Day 84
Mycological Response
Time Frame: Day 28, end of combined therapy and Day 84
Day 28, end of combined therapy and Day 84
Survival at Day 84
Time Frame: Day 84
Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma US, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

October 18, 2002

First Submitted That Met QC Criteria

October 23, 2002

First Posted (Estimate)

October 24, 2002

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-0-125
  • FG463-21-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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