Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

February 28, 2019

Study Completion Date

February 28, 2019

Conditions
Myasthenia Gravis
Interventions
DRUG

IGIV-C

"Run-Phase: 1 loading dose of 2 g/kg IGIV-C and 2 maintenance doses of 1 g/kg IGIV-C~Corticosteroid Tapering/IGIV-C Maintenance Phase: 1 g/kg IGIV-C every 3 weeks for up to 36 weeks"

DRUG

Placebo

Trial Locations (39)

1204

Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly, Budapest

2143

Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly, Kistarcsa

3000

UZ Leuven, Leuven

4779

Fachkrankenhaus Hubertusburg gGmbH, Klinik f. Neurologie, Wermsdorf

6120

Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie, Halle

6725

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7747

Universitaetsklinikum Jena, Klinik fuer Neurologie, Jena

10032

Columbia University Medical Center, New York

10117

Charité Universitaetsmedizin Berlin, Klinik für Neurologie, Berlin

10138

East Tallinn Central Hospital, Tallinn

19107

Thomas Jefferson University Hospital, Philadelphia

20246

Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik, Hamburg

30912

Georgia Regents University, Augusta

31059

CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale, Toulouse

32209

University of Florida at Shands Jacksonville, Jacksonville

33612

University of South Florida, Tampa

35043

Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg, Marburg

37075

Universitaetsmedizin Goettingen, Parent, Göttingen

43220

Ohio State University Wexner Medical Center, Neurology Department, Columbus

46202

Indiana University, Indianapolis

50161

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

66160

University of Kansas Medical Center Research Institute, Inc., Kansas City

67091

CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique, Strasbourg

77030

Houston Methodist Neurological Institute, Houston

92868

University of California-Irvine, Orange

93053

Universitaetsklinikum Regensburg, Parent, Regensburg

98105

University of Washington Medical Center, Seattle

06510

Yale University School of Medicine, Department of Neurology, New Haven

07103

Rutgers New Jersey Medical School, Newark

05405

University of Vermont Medical Center, Burlington

N6A 5A5

London Health Sciences Centre- University Hospital, London

M5G 2C4

University Health Network (UHN) - Toronto General Hospital, Toronto

625 00

Fakultni nemocnice Brno, Dept of Neurologicka klinika, Brno

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

128 21

Vseobecna fakultni nemocnice v Praze, Dept of Neurologicka klinika, Prague

80-952

Uniwersyteckie Centrum Kliniczne, Dept of Neurology, Gdansk

31-505

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej, Krakow

93-113

III Szpital Miejski w Lodzi im. Dr K. Jonschera, Lodz

02-097

Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY