A Multicenter, Prospective, Open-label, Non-controlled Clinical Trial to Assess the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Patients With Myasthenia Gravis Exacerbations
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Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.
Minimum Age: 18
Healthy Volunteers: No
• Was male or female aged ≥18 years.
• Subjects must be willing and able to provide written informed consent (if applicable, a legally authorized representative may provide informed consent on behalf of the subject).
• Subjects who met the clinical criteria for diagnosis of MG with an exacerbation defined as worsening of MG symptoms as defined by an Myasthenia Gravis Foundation of America (MGFA) classification IVb or V.
• Subjects on long-term (8 weeks) corticosteroid treatment for MG.
• Female subjects of child-bearing potential must have a negative test for pregnancy (human chorionic gonadotropin [HCG]-based assay).
• Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples, for the entire duration of the study.
Hospital General de Agudos Dr. J. M.
AZ St Lucas Gent
University of Alberta Hospital
London Health Sciences Centre
University Health Network (UHN) - Toronto General Hospital
East Tallinn Central Hospital
Hopital Neurologique Pierre Wertheimer
Hôpital Albert Michallon
Hopital Roger Salengro
Hôpital de la Timone
Hôpital Hautepierre Strasbourg
CHU de Toulouse - Hôpital Purpan
Jahn Ferenc Del-Pesti Korhaz
Pest Megyei Flor Ferenc Korhaz
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
University of Szeged, Faculty of Medicine
Zala Megyei Korhaz
Riga East Clinical University Hospital
Uniwersyteckie Centrum Kliniczne
Institutul Clinic Fundeni
Spitalul Clinic Judetean de Urgenta Targu-Mures
State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko
Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2
State Budgetary Institution of Healthcare Samara Regional Clinical Hospital. V.D.Seredavin
Groote Schuur Hospital,
Start Date:March 2015
Completion Date:April 2018
Target number of participants:49
Experimental: IGIV-C Treatment
In this arm, subjects with myasthenia gravis exacerbations were treated with an IV dose of 2 g/kg of IGIV-C, which was administered over 2 consecutive days at a dose of 1 g/kg per day.