Study Stopped
Due to administrative reasons
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
1 other identifier
interventional
43
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2014
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedNovember 20, 2024
November 1, 2024
1.3 years
December 16, 2015
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
At the end of the treatment (up to a maximum of 4 weeks)
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)
At the end of the treatment (up to a maximum of 12 weeks)
Secondary Outcomes (8)
Clinical improvement rate for patients with no hematology disease
Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Clinical Improvement rate for patients with hematology disease
Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fungal clearance rate for patients with no hematology disease
Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Fungal clearance rate for patients with hematology disease
Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fatality rate for patients with no hematology disease
End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
- +3 more secondary outcomes
Study Arms (1)
Micafungin group
EXPERIMENTALInjection
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Beijing, China
Unknown Facility
Changsha, China
Unknown Facility
Chengdu, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Harbin, China
Unknown Facility
Hefei, China
Unknown Facility
Hengyang, China
Unknown Facility
Jinan, China
Unknown Facility
Nanchan, China
Unknown Facility
Shanghai, China
Unknown Facility
Shijiazhuang, China
Unknown Facility
Suzhou, China
Unknown Facility
Taiyuan, China
Unknown Facility
Tianjing, China
Unknown Facility
Wenzhou, China
Unknown Facility
Wuhan, China
Unknown Facility
Zhengzhou, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2015
First Posted
January 6, 2016
Study Start
March 1, 2014
Primary Completion
June 26, 2015
Study Completion
June 26, 2015
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.