Back to resultsPost Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
Primary Purpose
Invasive Aspergillosis
Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Micafungin
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Aspergillosis focused on measuring Aspergillosis, Antifungal, Micafungin
Eligibility Criteria
Inclusion Criteria:
- Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
- Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Exclusion Criteria:
- Patient received any echinocandins drug within 1 month prior to enrollment.
- Patient was enrolled in any other clinical study within the last month.
- AST/ALT > 5 times the upper limit of normal (ULN)
- total bilirubin> 2.5 times ULN
- BUN/Ccr > 3 times ULN
- HIV positive patient
- Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
- Patient has a life expectancy of <1 month
- Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
- Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study.
- Patient has been previously enrolled in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micafungin group
Arm Description
Injection
Outcomes
Primary Outcome Measures
Overall success rate for patients with no hematology disease
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Overall success rate for patients with hematology disease
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Secondary Outcome Measures
Clinical improvement rate for patients with no hematology disease
Clinical Improvement rate for patients with hematology disease
Fungal clearance rate for patients with no hematology disease
Fungal clearance rate for patients with hematology disease
Fatality rate for patients with no hematology disease
Fatality rate for patients with hematology disease
Percentage of participants with common Aspergillus infection sites
Safety assessed by adverse events
Full Information
NCT ID
NCT02646774
First Posted
December 16, 2015
Last Updated
December 18, 2018
Sponsor
Astellas Pharma China, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02646774
Brief Title
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
Official Title
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to administrative reasons
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
June 26, 2015 (Actual)
Study Completion Date
June 26, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma China, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis
Keywords
Aspergillosis, Antifungal, Micafungin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micafungin group
Arm Type
Experimental
Arm Description
Injection
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
Injection
Primary Outcome Measure Information:
Title
Overall success rate for patients with no hematology disease
Description
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time Frame
At the end of the treatment (up to a maximum of 4 weeks)
Title
Overall success rate for patients with hematology disease
Description
Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time Frame
At the end of the treatment (up to a maximum of 12 weeks)
Secondary Outcome Measure Information:
Title
Clinical improvement rate for patients with no hematology disease
Time Frame
Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Title
Clinical Improvement rate for patients with hematology disease
Time Frame
Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Title
Fungal clearance rate for patients with no hematology disease
Time Frame
Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Title
Fungal clearance rate for patients with hematology disease
Time Frame
Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Title
Fatality rate for patients with no hematology disease
Time Frame
End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
Title
Fatality rate for patients with hematology disease
Time Frame
End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Title
Percentage of participants with common Aspergillus infection sites
Time Frame
End of treatment (up to 12 weeks)
Title
Safety assessed by adverse events
Time Frame
Up to 2 weeks after end of treatment (up to14 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG
Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study.
Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Exclusion Criteria:
Patient received any echinocandins drug within 1 month prior to enrollment.
Patient was enrolled in any other clinical study within the last month.
AST/ALT > 5 times the upper limit of normal (ULN)
total bilirubin> 2.5 times ULN
BUN/Ccr > 3 times ULN
HIV positive patient
Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
Patient has a life expectancy of <1 month
Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study.
Patient has been previously enrolled in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Changsha
Country
China
City
Chengdu
Country
China
City
Fuzhou
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Harbin
Country
China
City
Hefei
Country
China
City
Hengyang
Country
China
City
Jinan
Country
China
City
Nanchan
Country
China
City
Shanghai
Country
China
City
Shijiazhuang
Country
China
City
Suzhou
Country
China
City
Taiyuan
Country
China
City
Tianjing
Country
China
City
Wenzhou
Country
China
City
Wuhan
Country
China
City
Zhengzhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=167
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
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