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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00515450 |
Date of registration:
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10/08/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
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Scientific title:
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A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis |
Date of first enrolment:
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July 2007 |
Target sample size:
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46 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00515450 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), 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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Masaharu Takamori, Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Neurological Center Kanazawa-Nishi Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed as generalized myasthenia gravis
- Patients who are not controlled by current therapy and need plasmapheresis therapy
- Patients who have the high-dose steroid therapy for over a month in past years, and
also who take steroid or immunosuppressant on the day of consent
- Patients who had not any dose increase or new dosing of steroid or immunosuppressant
within 4 weeks prior to enrollment
Exclusion Criteria:
- Patients who received steroid pulse therapy, globulin therapy or plasmapheresis
therapy within 12 weeks prior to enrollment
- Patients who had undergone thymectomy within 24 weeks prior to enrollment
- Patients with 3 points item in bulbar symptom of MG-ADL scale
- Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
- Patients who have received treatment of malignant tumors
- Patients who have the anamnesis of shock or hypersensitivity to this drug
- Patients who have been diagnosed as hereditary fructose intolerance
- Patients who have the anamnesis of cerebral infarction or symptom of these diseases
- Patients who have been diagnosed as IgA deficiency in their past history
- Pregnant, lactating, and probably pregnant patients, and patients who want to become
pregnant
- Patients who were administered other investigational drug within 12 weeks before
consent
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Generalized Myasthenia Gravis
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Intervention(s)
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Procedure: Plasmapheresis
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Biological: GB-0998 (Intravenous immunoglobulin)
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Primary Outcome(s)
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Changes in QMG score
[Time Frame: at 4 weeks]
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Secondary Outcome(s)
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Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
[Time Frame: from beginning of the treatment through 4th week]
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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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