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

Generalized Myasthenia Gravis Clinical Trial

Official title:

A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515450
• Other study ID #: 0998-B1
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2007
• Last updated: July 29, 2010
• Start date: July 2007
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: Benesis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Myasthenia Gravis

Intervention

Biological:
• GB-0998 (Intravenous immunoglobulin)

Procedure:
• Plasmapheresis

Locations

Country	Name	City	State
Japan	Nagasaki University	Nagasaki

Sponsors (1)

Lead Sponsor	Collaborator
Benesis Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in QMG score		at 4 weeks
Secondary	Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels		from beginning of the treatment through 4th week