35
Participants
Start Date
September 30, 2007
Primary Completion Date
August 31, 2011
Study Completion Date
August 31, 2011
Gammaplex, intravenous immunoglobulin
"Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG).~The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX."
CER San Juan, San Juan
New York Hospital / Cornell University, Division of Pediatrics, New York
Center for Cancer & Blood Disorders, Bethesda
Mid Florida Hematology & Oncology, Orange City
Rush University Medical Center, Chicago
Cancer Care Centers of South Texas, San Antonio
Oregon Health & Science University, Portland
Sir Ganga Ram Hospital, New Delhi
S.K. Soni Hospital Sect 5, Jaipur
Vedanta, Ahmedabad
Gurukrupa Hospital, Ahmedabad
M S Patel Cancer Centre, Shree Krishna Hospital, Gokal Nagar, Karamsad
Deenanath Mangeshkar Hospital, Pune
Apollo Hospitals, Hyderabad
Mahavir Hospital, Hyderabad
City Cancer Centre,, Suryarao Pet, Vijayawada
Manipal Hospital, Bangalore
M. S Ramaiah Hospital, Karnataka
Kasturba Medical College, Manipal Acunova KMC Research Centre, Mangalore
Father Muller Medical College Hospital, Mangalore
Vinaya Hospital & research Centre, Mangalore
Department of Pediatrics, SUNY at Stony Brook, Stony Brook
Hospital Churruca, Capital Federal
Hospital Italiano de La Plata, La Plata
Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA), Rosario
I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento), Buenos Aires
Hospital Britanico, Buenos Aires
Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC), Buenos Aires
J.R. Vidal Hospital, Corrientes
Hospital Privado de Cordoba, Córdoba
Lead Sponsor
Bio Products Laboratory
OTHER