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Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Primary Purpose

Invasive Aspergillosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Micafungin
Systemic antifungal therapy
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Aspergillosis focused on measuring Invasive Aspergillosis, Salvage Therapy, Micafungin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

infusion for 3-12 weeks

infusion for 3-12 weeks

Outcomes

Primary Outcome Measures

Independent Data Review Board (IDRB) assessment of the overall success at the End of Treatment (EoT) defined as complete or partial clinical response.

Secondary Outcome Measures

Overall success at end of treatment

Full Information

First Posted
September 13, 2006
Last Updated
September 4, 2013
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00376337
Brief Title
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis
Keywords
Invasive Aspergillosis, Salvage Therapy, Micafungin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
infusion for 3-12 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
infusion for 3-12 weeks
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Systemic antifungal therapy
Intervention Description
IV
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Overall success at end of treatment
Time Frame
Weeks 3-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Buenos Aires
Country
Argentina
City
La Plata
Country
Argentina
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Belo Horizonte
Country
Brazil
City
Campinas
Country
Brazil
City
Curitiba
Country
Brazil
City
Goiania
Country
Brazil
City
Ipatinga
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Ribeirao Preto
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Santo Andre
Country
Brazil
City
Sao Paolo
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Bogota
Country
Colombia
City
Bucaramanga
Country
Colombia
City
Cali
Country
Colombia
City
Rijeka
Country
Croatia
City
Zagreb
Country
Croatia
City
Hradec Kralove
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Praha
ZIP/Postal Code
12820
Country
Czech Republic
City
Praha
Country
Czech Republic
City
Bobigny
Country
France
City
Dijon
ZIP/Postal Code
21034
Country
France
City
Dijon
Country
France
City
Paris Cedex 10
Country
France
City
Paris Cedex
Country
France
City
Pessac Cedex
Country
France
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Munich
Country
Germany
City
Munster
Country
Germany
City
Wuerzburg
Country
Germany
City
Budapest
Country
Hungary
City
Monza
Country
Italy
City
Pavia
Country
Italy
City
Rozzano
Country
Italy
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Poznan
Country
Poland
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Salamanca
Country
Spain
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda
Description
Link to FDA website
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=757
Description
Link to Results on JAPIC

Learn more about this trial

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

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