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

Benesis

Status and phase

Completed

Phase 3

Conditions

Generalized Myasthenia Gravis

Treatments

Procedure: Plasmapheresis

Biological: GB-0998 (Intravenous immunoglobulin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00515450

0998-B1

Details and patient eligibility

About

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

Enrollment

46 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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