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

July 29, 2010 updated by: Benesis Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8501
        • Nagasaki University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Procedure: Plasmapheresis
EXPERIMENTAL: 1
Biological: GB-0998 (Intravenous immunoglobulin)
Other Names:
  • Venoglobulin-IH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in QMG score
Time Frame: at 4 weeks
at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
Time Frame: from beginning of the treatment through 4th week
from beginning of the treatment through 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benesis Corporation

Investigators

  • Study Chair: Masaharu Takamori, Director, Neurological Center Kanazawa-Nishi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (ESTIMATE)

August 13, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2010

Last Update Submitted That Met QC Criteria

July 29, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0998-B1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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