Back to resultsA Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Primary Purpose
Fungemia, Fungal Infections
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
micafungin (Mycamine)
itraconazole
Sponsored by
About this trial
This is an interventional prevention trial for Fungemia focused on measuring Antifungal, micafungin, itraconazole
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1. Micafungin
2. Itraconazole
Arm Description
Outcomes
Primary Outcome Measures
Treatment success rate (fungal breakthrough rate)
Secondary Outcome Measures
Incidence of proven or probable invasive fungal infection
The usage rate of systemic antifungal agents
Time to treatment failure
Assessment of Adverse events, Laboratory examinations and vital signs evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00794703
Brief Title
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungemia, Fungal Infections
Keywords
Antifungal, micafungin, itraconazole
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Micafungin
Arm Type
Experimental
Arm Title
2. Itraconazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
micafungin (Mycamine)
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
itraconazole
Other Intervention Name(s)
Sporanox
Intervention Description
oral
Primary Outcome Measure Information:
Title
Treatment success rate (fungal breakthrough rate)
Time Frame
At the end of the study
Secondary Outcome Measure Information:
Title
Incidence of proven or probable invasive fungal infection
Time Frame
Throughout the study period
Title
The usage rate of systemic antifungal agents
Time Frame
During 4 weeks after the administration
Title
Time to treatment failure
Time Frame
During the study period
Title
Assessment of Adverse events, Laboratory examinations and vital signs evaluation
Time Frame
Throughout the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Fuzhou
State/Province
Fujian
Country
China
City
Wuhan
State/Province
Hubei
Country
China
City
Chengdu
State/Province
Sichuan
Country
China
City
Hangzhou
State/Province
Zhejiang
Country
China
City
Jiangsu
Country
China
City
Nanning
Country
China
City
Peking
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China
City
Xian
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22469884
Citation
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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=MCFGCN02-0
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
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