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
A Study for Patients With Generalized Myasthenia Gravis Using Intravenous Human Immunoglobulin Concentrate, IGIV-C.
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
Additional Study Information: 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
Thomas Brannagan, MD
Do You Qualify?
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
You may be eligible for this study

Place Holder

For more information, please contact:
Arreum Kim