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)

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.

Study Overview

• Status: Terminated
• Conditions: Invasive Aspergillosis
• Intervention / Treatment: Drug: Micafungin

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Changsha, China
  • Chengdu, China
  • Fuzhou, China
  • Guangzhou, China
  • Hangzhou, China
  • Harbin, China
  • Hefei, China
  • Hengyang, China
  • Jinan, China
  • Nanchan, China
  • Shanghai, China
  • Shijiazhuang, China
  • Suzhou, China
  • Taiyuan, China
  • Tianjing, China
  • Wenzhou, China
  • Wuhan, China
  • Zhengzhou, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micafungin group; Injection	Drug: Micafungin; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Astellas Pharma China, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): June 26, 2015
• Study Completion (Actual): June 26, 2015

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Micafungin; Aspergillosis; Antifungal
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Aspergillosis; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: ACN-MA-MYC-IA-2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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."