Micafungin Salvage Mono-therapy in Invasive Aspergillosis

September 4, 2013 updated by: Astellas Pharma Inc

A Phase II, Multicenter, Randomized, Open-label, Active Controlled Study to Evaluate the Safety and Efficacy of Micafungin Salvage Mono-therapy Versus Active Control Intravenous Salvage Mono-therapy in Patients With Invasive Aspergillosis

To evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. To compare the efficacy and safety of the micafungin therapy with the active control arm

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a phase II, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study.

Patients will be stratified according to the baseline infection status and the baseline neutropenic status:

  • Intolerant to previous antifungal therapy
  • Refractory to previous antifungal therapy; progression of infection
  • Refractory to previous antifungal therapy; failure to improve In case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory.
  • Neutropenic (absolute neutrophil count (ANC < 500 cells/mm3)
  • Non neutropenic (ANC >= 500 cells/mm3)

Study Type

Interventional

Enrollment (Actual)

17

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

  • Argentina
      • Buenos Aires, Argentina
      • La Plata, Argentina
  • Belgium
      • Aalst, Belgium, 9300
      • Bruxelles, Belgium
      • Gent, Belgium
      • Leuven, Belgium, 3000
  • Brazil
      • Belo Horizonte, Brazil
      • Campinas, Brazil
      • Curitiba, Brazil
      • Goiania, Brazil
      • Ipatinga, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Rio de Janeiro, Brazil
      • Santo Andre, Brazil
      • Sao Paolo, Brazil
      • Sao Paulo, Brazil
  • Colombia
      • Bogota, Colombia
      • Bucaramanga, Colombia
      • Cali, Colombia
  • Croatia
      • Rijeka, Croatia
      • Zagreb, Croatia
  • Czech Republic
      • Hradec Kralove, Czech Republic
      • Olomouc, Czech Republic, 77520
      • Praha, Czech Republic
      • Praha, Czech Republic, 12820
  • France
      • Bobigny, France
      • Dijon, France
      • Dijon, France, 21034
      • Paris Cedex, France
      • Paris Cedex 10, France
      • Pessac Cedex, France
  • Germany
      • Berlin, Germany
      • Bonn, Germany
      • Munich, Germany
      • Munster, Germany
      • Wuerzburg, Germany
  • Hungary
      • Budapest, Hungary
  • Italy
      • Monza, Italy
      • Pavia, Italy
      • Rozzano, Italy
  • Poland
      • Krakow, Poland
      • Lodz, Poland
      • Poznan, Poland
  • Spain
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Salamanca, Spain
      • Sevilla, Spain

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with HSCT, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin B or voriconazole products

Exclusion Criteria:

  • Patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
infusion for 3-12 weeks
Drug: Systemic antifungal therapy
IV
Experimental: 2
infusion for 3-12 weeks
Drug: Micafungin
IV
Other Names:
  • FK463

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.
Time Frame: Weeks 3-12
Weeks 3-12

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall success at end of treatment
Time Frame: Weeks 3-12
Weeks 3-12

Collaborators and Investigators

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

Sponsor

Astellas Pharma 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

June 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 14, 2006

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG463-21-20

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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