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Brief Title: Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis
Official Title: Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis
Study ID: NCT02100969
Brief Summary: The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
Detailed Description: Myasthenia gravis (MG) is a rare autoimmune disorder which causes the muscles to become weak because the immune system attacks the connection between the nerves and the muscles. Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). An immunoglobin is a blood protein. Hizentra is being studied for the treatment of patients with MG. Hizentra is administered by an injection into the skin through a portable infusion pump, which may be easier for patients to administer than the current treatments. Participants will be asked to complete 9 clinic visits and 3 telephone calls. It could take up to 30 weeks to complete all study visits.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Phoenix Neurological Associates, Phoenix, Arizona, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University at Buffalo, Buffalo, New York, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Toronto, Toronto, Ontario, Canada
Name: Mazen M Dimachkie, MD
Affiliation: University of Kansas Medical Center
Role: PRINCIPAL_INVESTIGATOR