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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:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00794703
First received: November 19, 2008
Last updated: February 8, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Fungemia
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:

U.S. FDA Resources

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)
Intravenous
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2. Itraconazole Drug: itraconazole
oral
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

  Eligibility

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

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

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

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00794703     History of Changes
Other Study ID Numbers: MCFGCN02-0
Study First Received: November 19, 2008
Last Updated: February 8, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Antifungal
micafungin
itraconazole

Additional relevant MeSH terms:
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Itraconazole
Hydroxyitraconazole
 Micafungin
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013