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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

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ClinicalTrials.gov Identifier: NCT02646800
Recruitment Status : Terminated (Due to administrative reasons)
First Posted : January 6, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

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.

Condition or disease Intervention/treatment Phase
Aspergillosis Candidiasis Drug: Micafungin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 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 Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp
Actual Study Start Date : March 21, 2014
Actual Primary Completion Date : December 21, 2014
Actual Study Completion Date : December 21, 2014


Arm Intervention/treatment
Experimental: Micafungin group
Intravenous (IV)
Drug: Micafungin
Injection




Primary Outcome Measures :
  1. Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis [ Time Frame: Up to a maximum of 10 weeks ]
  2. Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis [ Time Frame: Up to a maximum of 14 weeks ]
  3. Safety as assessed by adverse reactions for patients with candidiasis [ Time Frame: Up to a maximum of 10 weeks ]
  4. Safety as assessed by adverse reactions for patients with aspergillosis [ Time Frame: Up to a maximum of 14 weeks ]

Secondary Outcome Measures :
  1. Overall success 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) ]
    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)

  2. Overall success rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) ]
    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)

  3. 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 ]
  4. Clinical Improvement rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) ]
  5. 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) ]
  6. Fungal clearance rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients ]
  7. 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) ]
  8. Fatality rate for patients with aspergillosis [ Time Frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]


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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/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.

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): NCT02646800


Locations
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China
Beijing, China
Changchun, China
Chongqing, China
Fuzhou, China
Guangzhou, China
Hangzhou, China
Harbin, China
Hengyang, China
Jinan, China
Nanjing, China
Qingdao, China
Shijiazhuang, China
Taiyuan, China
Tianjing, China
Urumchi, China
Xi'an, 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: NCT02646800     History of Changes
Other Study ID Numbers: ACN-MA-MYC-registry-2013
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
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. ):
Micafungin
Antifungal
Candidiasis
Aspergillosis
Additional relevant MeSH terms:
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Candidiasis
Mycoses
Aspergillosis
Micafungin
Antifungal Agents
Anti-Infective Agents