Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Sponsor

Astellas Pharma China, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02646774

Collaborator

(none)

Enrollment

Locations

Arm

15.8

Actual Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Aspergillosis	Drug: Micafungin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jun 26, 2015

Actual Study Completion Date :

Jun 26, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Micafungin group Injection	Drug: Micafungin Injection

Arm

Intervention/Treatment

Experimental: Micafungin group

Injection

Drug: Micafungin

Injection

Outcome Measures

Primary Outcome Measures

Overall success rate for patients with no hematology disease [At the end of the treatment (up to a maximum of 4 weeks)]
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 [At the end of the treatment (up to a maximum of 12 weeks)]
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 [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)]
Fatality rate for patients with hematology disease [End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)]
Percentage of participants with common Aspergillus infection sites [End of treatment (up to 12 weeks)]
Safety assessed by adverse events [Up to 2 weeks after end of treatment (up to14 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	Country
1	Beijing	China
2	Changsha	China
3	Chengdu	China
4	Fuzhou	China
5	Guangzhou	China
6	Hangzhou	China
7	Harbin	China
8	Hefei	China
9	Hengyang	China
10	Jinan	China
11	Nanchan	China
12	Shanghai	China
13	Shijiazhuang	China
14	Suzhou	China
15	Taiyuan	China
16	Tianjing	China
17	Wenzhou	China
18	Wuhan	China
19	Zhengzhou	China