A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis
Sponsor: |
Grifols Therapeutics, Inc. |
Enrolling: |
Male and Female Patients |
Clinic Visits: |
15 |
IRB Number: |
AAAQ6544 |
U.S. Govt. ID: |
NCT02473952 |
Contact: |
Arreum Kim: 2123056035 / ak3905@cumc.columbia.edu |
This study is designed to test how well an intravenous human immunoglobulin concentrate, IGIV-C (compared with placebo) improves your muscle weakness associated with MG symptoms. A placebo is a medication that looks like the study medication but has no active ingredient. Immunoglobulin is an antibody produced by white blood cells that is used by the immune system (body protection system) to identify and neutralize foreign objects (such as viruses, bacteria, antibodies, etc). In MG treatment, human immunoglobulins are used to potentially affect the function or production of the abnormal antibodies occurring in MG patients.
This study is closed
Investigator
Thomas Brannagan, MD
Anti-AChR antibody positive? |
Yes |
No |
Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months? |
Yes |
No |
Thymectomy within the preceding six months? |
Yes |
No |
Have received immune globulin (Ig) treatment given by IV, subcutaneous, or intramuscular route within the last 3 months? |
Yes |
No |
Plasma exchange (PLEX) performed within the last 3 months? |
Yes |
No |