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

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myasthenia Gravis

Intervention: HIZENTRA ® (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Mazen Dimachkie, MD

Official(s) and/or principal investigator(s):
Mazen M Dimachkie, MD, Principal Investigator, Affiliation: University of Kansas

Overall contact:
Gabrielle Rico, Phone: (913) 588-5703, Email: grico@kumc.edu

Summary

The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in MG severity

Secondary outcome:

Efficacy of SCIg in MG

Safety and tolerability of SCIg in people with MG

Number of Participants with Serious and Non-Serious Adverse Events

Effect of SCIg on IgG antibody levels

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must have MGFA MG grades 2, 3, or 4 generalized MG, according to the MGFA

classification system

- Elevated AChR or MuSK Ab

- Patient's signs and symptoms should not be better explained by another disease

process

- IVIg maintenance dose of 0. 2 to 2 gm/kg/4 weeks or equivalent dose administered every

2-4 weeks

- Stable IVIg for at least 3 cycles

- Able to complete the study and return for follow-up visits

- Able to give written informed consent before participating in the study

Exclusion Criteria:

- History of chronic degenerative, psychiatric, or neurologic disorder other than MG

that can produce weakness or fatigue

- Other major chronic or debilitating illnesses within six months prior to study entry

- Female patients who are premenopausal and are (a) pregnant, (b) breastfeeding, or (c)

not using an effective method of double barrier birth control

- Altered levels of consciousness, dementia, or abnormal mental status

- Thymectomy in the previous three months

- History of renal insufficiency or liver disease

- Skin disease that would interfere with assessment of injection site reaction

- History of severe reactions to IVIg or SCIg

- Participation in a research study within the last 3 months

- Treatment with rituximab or other biologics within 12 months of study entry

- Unable to provide informed consent

Locations and Contacts

Gabrielle Rico, Phone: (913) 588-5703, Email: grico@kumc.edu

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Additional Information

Starting date: January 2015
Last updated: April 28, 2015

Page last updated: August 23, 2015

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