NCT02100969

Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Mazen Dimachkie, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	HIZENTRA ®	Patients must fulfill inclusion criteria and remain stable at week 0, which means QMG does not increase by 3 points, will enter receive Hizentra for 12 weeks.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-11-01
• Completion: 2018-01-01
• First posted: 2014-04-01
• Last updated: 2021-06-02
• Results posted: 2019-12-13

Locations

5 sites across 2 countries: United States, Canada