Back to resultsEfficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Primary Purpose
Generalized Myasthenia Gravis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GB-0998 (Intravenous immunoglobulin)
Plasmapheresis
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring Myasthenia Gravis
Eligibility Criteria
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
Sites / Locations
- Nagasaki University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Changes in QMG score
Secondary Outcome Measures
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00515450
Brief Title
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Official Title
A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Benesis Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
Myasthenia Gravis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
GB-0998 (Intravenous immunoglobulin)
Other Intervention Name(s)
Venoglobulin-IH
Intervention Type
Procedure
Intervention Name(s)
Plasmapheresis
Primary Outcome Measure Information:
Title
Changes in QMG score
Time Frame
at 4 weeks
Secondary Outcome Measure Information:
Title
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Time Frame
from beginning of the treatment through 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaharu Takamori, Director
Organizational Affiliation
Neurological Center Kanazawa-Nishi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nagasaki University
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
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