A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis

Status: Completed
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a corticosteroid (CS)-sparing agent in subjects with CS-dependent Myasthenia Gravis (MG).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

• Anti-acetylcholine receptor antibody positive

• Confirmed diagnosis of generalized MG historically meeting the clinical criteria for diagnosis of MG defined by the Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, IV, or V historically

• At Screening, subjects may have symptoms controlled by CS or were MGFA Class II-IVa inclusive (Class IVb and Class V excluded). Subjects who only have a history of ocular MG may not enroll.

• On systemic CS for a minimum period of at least 3 months and on a stable CS dose of >=15 mg/day and <=60 mg/day (prednisone equivalent) for the month prior to Screening.

• Had a tapering CS dose that the study investigator considered to be appropriate.

• At least 1 previous completed attempt to taper CS in order to minimize CS dose (lowest feasible dose based on observed MG signs and symptoms)

Locations
United States
California
University of California-Irvine
Orange
Connecticut
Yale University School of Medicine, Department of Neurology
New Haven
Florida
University of Florida at Shands Jacksonville
Jacksonville
University of South Florida
Tampa
Georgia
Georgia Regents University
Augusta
Indiana
Indiana University
Indianapolis
Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City
New Jersey
Rutgers New Jersey Medical School
Newark
New York
Columbia University Medical Center
New York
Ohio
Ohio State University Wexner Medical Center, Neurology Department
Columbus
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
Texas
Houston Methodist Neurological Institute
Houston
Vermont
University of Vermont Medical Center
Burlington
Washington
University of Washington Medical Center
Seattle
Other Locations
Belgium
UZ Leuven
Leuven
Canada
London Health Sciences Centre- University Hospital
London
University Health Network (UHN) - Toronto General Hospital
Toronto
Estonia
East Tallinn Central Hospital
Tallinn
France
CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique
Strasbourg Cedex
CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale
Toulouse Cedex 9
Germany
Charité Universitaetsmedizin Berlin, Klinik für Neurologie
Berlin
Universitaetsmedizin Goettingen, Parent
Göttingen
Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie
Halle
Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik
Hamburg
Universitaetsklinikum Jena, Klinik fuer Neurologie
Jena
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg
Universitaetsklinikum Regensburg, Parent
Regensburg
Fachkrankenhaus Hubertusburg gGmbH, Klinik f. Neurologie
Wermsdorf
Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly
Budapest
Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly
Kistarcsa
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
Poland
Uniwersyteckie Centrum Kliniczne, Dept of Neurology
Gdansk
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej
Krakow
III Szpital Miejski w Lodzi im. Dr K. Jonschera
Lodz
Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa
Time Frame
Start Date: June 2015
Completion Date: February 2019
Participants
Target number of participants: 60
Treatments
Experimental: IGIV-C
An IGIV-C loading dose of 2 g/kg and maintenance dose of 1 g/kg will be administered in CS dependent subjects with MG.
Placebo Comparator: Placebo
0.9% sodium chloride injection, USP or equivalent
Sponsors
Leads: Grifols Therapeutics LLC

This content was sourced from clinicaltrials.gov

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