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Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Primary Purpose

Aspergillosis, Candidiasis

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Micafungin
Sponsored by
Astellas Pharma China, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis focused on measuring Micafungin, Antifungal, Candidiasis, Aspergillosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are diagnosed as proven/probable/possible fungal infection caused by Candida or Aspergillus based on the Chinese guidelines
  • Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to the study and reliable methods of contraception should be started 4 weeks prior to and 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.
  • Failure to fulfill inclusion criteria in another study, is not necessarily an exclusion criteria for this study, assuming other inclusion criteria 1-4 stated above are fulfilled.

Exclusion Criteria:

  • Patient has history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
  • 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.
  • AST/ALT > 5 times the upper limit of normal (ULN)
  • Total bilirubin> 2.5 times ULN
  • 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

Intravenous (IV)

Outcomes

Primary Outcome Measures

Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis
Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis
Safety as assessed by adverse reactions for patients with candidiasis
Safety as assessed by adverse reactions for patients with aspergillosis

Secondary Outcome Measures

Overall success rate for patients with candidiasis
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Overall success rate for patients with aspergillosis
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Clinical Improvement rate for patients with candidiasis
Clinical Improvement rate for patients with aspergillosis
Fungal clearance rate for patients with candidiasis
Fungal clearance rate for patients with aspergillosis
Fatality rate for patients with candidiasis
Fatality rate for patients with aspergillosis
Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis
Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis
Safety as assessed by liver and kidney function for patients with candidiasis
Safety as assessed by liver and kidney function for patients with aspergillosis

Full Information

First Posted
December 16, 2015
Last Updated
January 21, 2019
Sponsor
Astellas Pharma China, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02646800
Brief Title
Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp
Official Title
A Multi-center, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to administrative reasons
Study Start Date
March 21, 2014 (Actual)
Primary Completion Date
December 21, 2014 (Actual)
Study Completion Date
December 21, 2014 (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 safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis, Candidiasis
Keywords
Micafungin, Antifungal, Candidiasis, Aspergillosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micafungin group
Arm Type
Experimental
Arm Description
Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
Injection
Primary Outcome Measure Information:
Title
Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis
Time Frame
Up to a maximum of 10 weeks
Title
Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis
Time Frame
Up to a maximum of 14 weeks
Title
Safety as assessed by adverse reactions for patients with candidiasis
Time Frame
Up to a maximum of 10 weeks
Title
Safety as assessed by adverse reactions for patients with aspergillosis
Time Frame
Up to a maximum of 14 weeks
Secondary Outcome Measure Information:
Title
Overall success rate for patients with candidiasis
Description
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time Frame
End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Title
Overall success rate for patients with aspergillosis
Description
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)
Time Frame
End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Title
Clinical Improvement rate for patients with candidiasis
Time Frame
End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis
Title
Clinical Improvement rate for patients with aspergillosis
Time Frame
End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Title
Fungal clearance rate for patients with candidiasis
Time Frame
End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Title
Fungal clearance rate for patients with aspergillosis
Time Frame
End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Title
Fatality rate for patients with candidiasis
Time Frame
End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Title
Fatality rate for patients with aspergillosis
Time Frame
End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Title
Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis
Time Frame
Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Title
Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis
Time Frame
Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Title
Safety as assessed by liver and kidney function for patients with candidiasis
Time Frame
Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Title
Safety as assessed by liver and kidney function for patients with aspergillosis
Time Frame
Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients)

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/probable/possible fungal infection caused by Candida or Aspergillus based on the Chinese guidelines Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to the study and reliable methods of contraception should be started 4 weeks prior to and 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. Failure to fulfill inclusion criteria in another study, is not necessarily an exclusion criteria for this study, assuming other inclusion criteria 1-4 stated above are fulfilled. Exclusion Criteria: Patient has history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins. 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. AST/ALT > 5 times the upper limit of normal (ULN) Total bilirubin> 2.5 times ULN 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
Changchun
Country
China
City
Chongqing
Country
China
City
Fuzhou
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Harbin
Country
China
City
Hengyang
Country
China
City
Jinan
Country
China
City
Nanjing
Country
China
City
Qingdao
Country
China
City
Shijiazhuang
Country
China
City
Taiyuan
Country
China
City
Tianjing
Country
China
City
Urumchi
Country
China
City
Xi'an
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/hcp/study.aspx?ID=ACN-MA-MYC-registry-2013
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

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