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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00309101 |
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Date of registration:
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29/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
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Scientific title:
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FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00309101 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Inc |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinically diagnosed as myasthenia gravis
- Those whose MG symptoms are not controlled by the treatment with prednisone
Exclusion Criteria:
- Those who had undergone thymectomy
Age minimum:
16 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis
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Intervention(s)
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Drug: tacrolimus
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Primary Outcome(s)
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Improvement of clinical symptoms
[Time Frame: 28 Weeks]
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Secondary Outcome(s)
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Improvement of daily activity
[Time Frame: 28 Weeks]
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Secondary ID(s)
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F506-CL-0602
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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