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Trial record 3 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

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

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ClinicalTrials.gov Identifier: NCT02646774
Recruitment Status : Terminated (Due to administrative reasons)
First Posted : January 6, 2016
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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 : March 1, 2014
Actual Primary Completion Date : June 26, 2015
Actual Study Completion Date : June 26, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

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




Primary Outcome Measures :
  1. Overall success rate for patients with no hematology disease [ Time Frame: 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)

  2. Overall success rate for patients with hematology disease [ Time Frame: 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 :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Percentage of participants with common Aspergillus infection sites [ Time Frame: End of treatment (up to 12 weeks) ]
  8. Safety assessed by adverse events [ Time Frame: Up to 2 weeks after end of treatment (up to14 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646774


Locations
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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
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT02646774     History of Changes
Other Study ID Numbers: ACN-MA-MYC-IA-2012
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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."

Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
Aspergillosis
Antifungal
Micafungin

Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Micafungin
Antifungal Agents
Anti-Infective Agents