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

Status: Completed
Location: See all (28) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
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• 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.

Locations
Other Locations
Argentina
Hospital General de Agudos Dr. J. M.
Buenos Aires
Hospital Italiano
Buenos Aires
Hospital Cordoba
Cordoba
Belgium
AZ St Lucas Gent
Ghent
UZ Leuven
Leuven
Canada
University of Alberta Hospital
Edmonton
London Health Sciences Centre
London
University Health Network (UHN) - Toronto General Hospital
Toronto
Estonia
East Tallinn Central Hospital
Tallinn
France
Hopital Neurologique Pierre Wertheimer
Bron
Hôpital Albert Michallon
Grenoble
Hopital Roger Salengro
Lille
Hôpital de la Timone
Marseille
Hôpital Hautepierre Strasbourg
Strasbourg
CHU de Toulouse - Hôpital Purpan
Toulouse
Hungary
Jahn Ferenc Del-Pesti Korhaz
Budapest
Pest Megyei Flor Ferenc Korhaz
Kistarcsa
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyíregyháza
University of Szeged, Faculty of Medicine
Szeged
Zala Megyei Korhaz
Zalaegerszeg
Latvia
Riga East Clinical University Hospital
Riga
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Romania
Institutul Clinic Fundeni
Bucuresti
Spitalul Clinic Judetean de Urgenta Targu-Mures
Targu Mures
Russian Federation
State Budgetary Institution of Healthcare of Nizhniy Novgorod region. Nizhniy Novgorod Regional Clinical Hospital named after N.A.Semashko
Nizhniy Novgorod
Saint-Petersburg State Budgetary Institution of Healthcare. City Multi-field Hospital # 2
Saint Petersburg
State Budgetary Institution of Healthcare Samara Regional Clinical Hospital. V.D.Seredavin
Samara
South Africa
Groote Schuur Hospital,
Cape Town
Time Frame
Start Date: March 2015
Completion Date: April 2018
Participants
Target number of participants: 49
Treatments
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.
Authors
Christophe Vial, Emmeline Lagrange, David Brassat, Celine Tard, Christine Tranchant, Jean Pouget, Jan De Bleecker, Janos Nikl, Crisanda Vilciu, Peter Dioszeghy, Irina Poverennova, Michael Nicolle, Philip Van Damme, Josef Bednarik, Gyula Pánzél, Zaeem Sidiqqi, Alexander Gustov, Csaba Hoffmann, Fatima Stuchevskaya, Guntis Karellis, Maria Elena Abdel Masih, Malgorzata Bilinska, Laszlo Vecsei, Petr Hon, Vera Bril, Toomas Toomsoo, Rodica Ioana Balasa, Andrejs Millers, Jeannine Heckmann, Michaela Tyblova, Angela Genge, Marcelo Rugiero, Andres Villa
Sponsors
Leads: Grifols Therapeutics LLC

This content was sourced from clinicaltrials.gov