Therapeutic Plasma Exchange in MG

Completed

Conditions studied: Myasthenia Gravis

In brief

The primary objective of the study is to longitudinally profile immunoglobulin levels and autoantibody levels in subjects with myasthenia gravis (MG) who receive therapeutic plasma exchange (TPE).

Key facts

Study ID

NCT01927692

Run by

Duke University

People needed

11

Starts

2013-07-01

Expected to finish

2014-10-01

Last updated by the study team

2015-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• has the capacity to understand and sign an informed consent form
• 18 years or older
• diagnosis of MG based on clinical features
• has detectable serum autoantibodies to AChR
• has a clinical indication for the use of TPE to treat MG

You may not qualify if…

• unable or unwilling to comply with study procedures that include multiple venipunctures
• weighs less than 50Kg
• has a contraindication to treatment with TPE (e.g. clinically significant bleeding disorder)
• has muscle specific tyrosine kinase or low-density lipoprotein receptor-related protein 4 (LRP4) antibody positive MG
• has prior or current history of thymoma
• had a thymectomy in the past 6 months
• has received rituximab in the past 12 months
• has another coexisting autoimmune disease that is not clinically controlled or may preclude accurate study assessments according to the judgment of the PI
• has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or central nervous system disease
• has participated in an interventional clinical trial with a novel therapeutic agent in the past 6 months
• is cognitively impaired, a prisoner, or otherwise institutionalized at the time of screening

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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