117
Participants
Start Date
April 30, 2004
Primary Completion Date
June 30, 2006
Study Completion Date
June 30, 2006
Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified
2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Albumin (Human) 25%, United States Pharmacopeia (USP)
Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Fakultní nemocnice Ostrava, Ostrava-Poruba
Columbia University, New York
University Hospital, University of Belgrade, Belgrade
Jüdisches Krankenhaus, Berlin
Fakultní nemocnice Motol, Prague
Univesita delgi Studi di Genova, Dipartimento di Scienze, Neurologiche e della Visione, Genova
Hospital San Raffaele, Milan
Cleveland Clinic, Cleveland
Antiguo Hospital Civil de Guadalajara, Guadalajara
Neurologická klinika Pardubice, Pardubice
Saint Louis University Medical Center, St Louis
Assaf Harofe Medical Center, Zrifin
University of Texas-Southwestern Medical Center at Dallas, Dallas
Tel Aviv Sourasky Medical Center, Tel Aviv
Yale University School of Medicine, New Haven
Wake Forest University-School of Medicine, Winston-Salem
Hospital Ramos Mejia, Buenos Aires
Hospital Frances, Buenos Aires
Fundacion para la Lucha contra Las Enfermedades Neurologicas de la Infacia (FLENI), Buenos Aires
Instituto de Neurociencias Buenos Aires (INEBA), Capital Federal
Vancouver Hospital and Health Sciences Center, Vancouver
Fakultní nemocnice Brno, Brno
Chaim Sheba Medical Center, Tel Litwinsky
Dipartimento di Neuroscienze, Sezione di Neurologia, AO Chieti, Chieti
Hospital Angel Leano, Neurology Department, Guadalajara
Hospital Central San Luis Potosi, Neurology Department, San Luis Potosí City
Central Clinical Hospital, Medical Academy Warsaw, Warsaw
County Hospital, Zgierz
County Specialist Hospital, Neurology Department, Gdansk
Centre of Clinical Neurology, Neurology Department, Krakow
Barlicki Hospital, Lodz
Medical Acedemy, Clinical Hospital, Neurology Department, Lubin
Lead Sponsor
Grifols Therapeutics LLC
INDUSTRY