Text Size

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

This study has been terminated.
(Study was stopped due to difficulties in recruitment and changes in standard care for invasive aspergillosis)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00376337
First received: September 13, 2006
Last updated: October 18, 2011
Last verified: October 2011
History of Changes

September 13, 2006
October 18, 2011
June 2006
September 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00376337 on ClinicalTrials.gov Archive Site
Overall success at end of treatment [ Time Frame: Weeks 3-12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Micafungin Salvage Mono-therapy in Invasive Aspergillosis
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

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)
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Invasive Aspergillosis
  • Drug: Micafungin
    IV
    Other Name: FK463
  • Drug: Systemic antifungal therapy
    IV
  • Active Comparator: 1
    infusion for 3-12 weeks
    Intervention: Drug: Systemic antifungal therapy
  • Experimental: 2
    infusion for 3-12 weeks
    Intervention: Drug: Micafungin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Colombia,   Croatia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Spain
 
NCT00376337
FG463-21-20
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma Europe BV
Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP