A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00794703
First received: November 19, 2008
Last updated: February 8, 2010
Last verified: February 2010

November 19, 2008
February 8, 2010
November 2008
November 2009   (final data collection date for primary outcome measure)
Treatment success rate (fungal breakthrough rate) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794703 on ClinicalTrials.gov Archive Site
  • Incidence of proven or probable invasive fungal infection [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
  • The usage rate of systemic antifungal agents [ Time Frame: During 4 weeks after the administration ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: During the study period ] [ Designated as safety issue: No ]
  • Assessment of Adverse events, Laboratory examinations and vital signs evaluation [ Time Frame: Throughout the study period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Fungemia
  • Fungal Infections
  • Drug: micafungin (Mycamine)
    Intravenous
    Other Names:
    • Mycamine
    • FK463
  • Drug: itraconazole
    oral
    Other Name: Sporanox
  • Experimental: 1. Micafungin
    Intervention: Drug: micafungin (Mycamine)
  • Active Comparator: 2. Itraconazole
    Intervention: Drug: itraconazole
Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:

    • Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
    • Any patient undergoing an allogeneic hematopoietic stem cell transplant

Exclusion Criteria:

  • Patients with moderate or severe liver disease, as defined by:

    • AST or ALT greater than 5 times upper limit of normal (ULN), OR;
    • Total bilirubin greater than 2.5 times ULN
  • Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00794703
MCFGCN02-0
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
February 2010

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