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Sponsored by: |
Benesis Corporation |
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Information provided by: | Benesis Corporation |
ClinicalTrials.gov Identifier: | NCT00515450 |
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
Condition | Intervention | Phase |
---|---|---|
Generalized Myasthenia Gravis |
Biological: GB-0998 (Intravenous immunoglobulin) Procedure: Plasmapheresis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis |
Estimated Enrollment: | 46 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | May 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Biological: GB-0998 (Intravenous immunoglobulin) |
2: Active Comparator | Procedure: Plasmapheresis |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yoshiyuki Fukushima | +81-6-6227-5295 | 5802155@cc.m-pharma.co.jp |
Japan | |
Nagasaki University | Recruiting |
Nagasaki, Japan, 852-8501 | |
Principal Investigator: Masakatsu Motomura, Assist. Prof |
Study Chair: | Masaharu Takamori, Director | Neurological Center Kanazawa-Nishi Hospital |
Study ID Numbers: | 0998-B1 |
Study First Received: | August 10, 2007 |
Last Updated: | August 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00515450 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Myasthenia Gravis |
Antibodies Autoimmune Diseases Neuromuscular Diseases Immunoglobulins, Intravenous Myasthenia gravis |
Rho(D) Immune Globulin Myasthenia Gravis Autoimmune Diseases of the Nervous System Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs |
Nervous System Diseases Neuromuscular Junction Diseases Pharmacologic Actions |