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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: November 19, 2008
Last updated: March 25, 2016
Last verified: March 2016
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

Condition Intervention Phase
Fungal Infections
Drug: micafungin (Mycamine)
Drug: itraconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Treatment success rate (fungal breakthrough rate) [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 288
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Micafungin Drug: micafungin (Mycamine)
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2. Itraconazole Drug: itraconazole
Other Name: Sporanox

Detailed Description:
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794703

China, Fujian
Fuzhou, Fujian, China
China, Hubei
Wuhan, Hubei, China
China, Sichuan
Chengdu, Sichuan, China
China, Zhejiang
Hangzhou, Zhejiang, China
Jiangsu, China
Nanning, China
Peking, China
Shanghai, China
Tianjin, China
Xian, China
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00794703     History of Changes
Other Study ID Numbers: MCFGCN02-0 
Study First Received: November 19, 2008
Last Updated: March 25, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Steroid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016