Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Phase 3

Completed

• Conditions: Generalized Myasthenia Gravis
• Interventions: Biological: GB-0998 (Intravenous immunoglobulin); Procedure: Plasmapheresis

• Registration Number: NCT00515450
• Lead Sponsor: Benesis Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-10
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-13
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-29
• Last Update Posted: 2010-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GB-0998 (Intravenous immunoglobulin)	-
2	Plasmapheresis	-

Primary Outcome Measures

Name	Time	Method
Changes in QMG score	at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels	from beginning of the treatment through 4th week

Trial Locations

Locations (1)

Nagasaki University; 🇯🇵 Nagasaki, Japan