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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794703
First Posted: November 20, 2008
Last Update Posted: March 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
November 19, 2008
November 20, 2008
March 28, 2016
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 ]
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 ]
  • The usage rate of systemic antifungal agents [ Time Frame: During 4 weeks after the administration ]
  • Time to treatment failure [ Time Frame: During the study period ]
  • Assessment of Adverse events, Laboratory examinations and vital signs evaluation [ Time Frame: Throughout the study period ]
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
Intervention Model: Parallel Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00794703
MCFGCN02-0
No
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
March 2016

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