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

Primary Purpose

Generalized Myasthenia Gravis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
GB-0998 (Intravenous immunoglobulin)
Plasmapheresis
Sponsored by
Benesis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring Myasthenia Gravis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nagasaki University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Changes in QMG score

Secondary Outcome Measures

Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels

Full Information

First Posted
August 10, 2007
Last Updated
July 29, 2010
Sponsor
Benesis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00515450
Brief Title
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Official Title
A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Benesis Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
GB-0998 (Intravenous immunoglobulin)
Other Intervention Name(s)
Venoglobulin-IH
Intervention Type
Procedure
Intervention Name(s)
Plasmapheresis
Primary Outcome Measure Information:
Title
Changes in QMG score
Time Frame
at 4 weeks
Secondary Outcome Measure Information:
Title
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Time Frame
from beginning of the treatment through 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaharu Takamori, Director
Organizational Affiliation
Neurological Center Kanazawa-Nishi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nagasaki University
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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