Trials / Completed
CompletedNCT00515450
Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Benesis Corporation · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GB-0998 (Intravenous immunoglobulin) | |
| PROCEDURE | Plasmapheresis |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2010-05-01
- Completion
- 2010-06-01
- First posted
- 2007-08-13
- Last updated
- 2010-07-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00515450. Inclusion in this directory is not an endorsement.