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

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.
ClinicalTrials.gov Identifier: NCT00794703
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Fungemia Fungal Infections Drug: micafungin (Mycamine) Drug: itraconazole Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1. Micafungin Drug: micafungin (Mycamine)
Intravenous
Other Names:
  • Mycamine
  • FK463
Active Comparator: 2. Itraconazole Drug: itraconazole
oral
Other Name: Sporanox


Outcome Measures

Primary Outcome Measures :
  1. Treatment success rate (fungal breakthrough rate) [ Time Frame: At the end of the study ]

Secondary Outcome Measures :
  1. Incidence of proven or probable invasive fungal infection [ Time Frame: Throughout the study period ]
  2. The usage rate of systemic antifungal agents [ Time Frame: During 4 weeks after the administration ]
  3. Time to treatment failure [ Time Frame: During the study period ]
  4. Assessment of Adverse events, Laboratory examinations and vital signs evaluation [ Time Frame: Throughout the study period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Antifungal
micafungin
itraconazole

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Fungemia
Sepsis
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Itraconazole
Hydroxyitraconazole
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors