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

NCT ID: NCT00515450

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Generalized Myasthenia Gravis

Keywords

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Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

GB-0998 (Intravenous immunoglobulin)

Intervention Type BIOLOGICAL

2

Group Type ACTIVE_COMPARATOR

Plasmapheresis

Intervention Type PROCEDURE

Interventions

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GB-0998 (Intravenous immunoglobulin)

Intervention Type BIOLOGICAL

Plasmapheresis

Intervention Type PROCEDURE

Other Intervention Names

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Venoglobulin-IH

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benesis Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Masaharu Takamori, Director

Role: STUDY_CHAIR

Neurological Center Kanazawa-Nishi Hospital

Locations

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Nagasaki University

Nagasaki, Nagasaki, Japan

Site Status

Countries

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Japan

Other Identifiers

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0998-B1

Identifier Type: -

Identifier Source: org_study_id