208
Participants
Start Date
March 31, 2012
Primary Completion Date
September 30, 2016
Study Completion Date
September 30, 2016
IgPro20 (low dose)
"20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:~0.2 g/kg body weight (low dose arm)"
Placebo
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
IgPro10
10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.
IgPro20 (high dose)
"20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:~0.4 g/kg body weight (high dose arm)"
Site Reference 0360017, Herston
Site reference 8400169, New York
Site reference 8400179, New York
Site Reference 2330002, Tallinn
Site Reference 2330003, Tallinn
Site Reference 8400352, Washington D.C.
Site Reference 8400268, Charlottesville
Site Reference 8400346, Durham
Site reference 8400182, Charlotte
Site reference 8400214, Miami
Site reference 8400181, Birmingham
Site Reference 8400177, Nashville
Site reference 8400178, Columbus
Site Reference 2760094, Essen
Site Reference 8400215, Indianapolis
Site Reference 2760113, Ibbenbueren
Site reference 8400162, Chicago
Site Reference 8400247, Chicago
Site reference 8400166, Kansas City
Site reference 8400217, Oklahoma City
Site reference 8400164, Houston
Site reference 8400077, Centennial
Site reference 8400173, Phoenix
Site reference 8400172, Phoenix
Site reference 8400167, Los Angeles
Site Reference 8400340, Seattle
Site Reference 8400347, New Brunswick
Site reference 0360011, Fitzroy
Site reference 0360008, Southport
Site reference 0560003, Leuven
Site reference 1240006, Edmonton
Site reference 1240007, Québec
Site reference 1240009, Toronto
Site reference 2030002, Hradec Králové
Site reference 2030009, Hradec Králové
Site reference 2030003, Prague
Site reference 2460002, Helsinki
Site reference 2500024, Clermont-Ferrand
Site reference 2500013, Marseille
Site reference 2500022, Nice
Site reference 2500019, Pessac
Site reference 2760048, Berlin
Site reference 2760069, Berlin
Site reference 2760072, Berlin
Site reference 2760049, Bochum
Site reference 2760080, Cologne
Site reference 2760075, Düsseldorf
Site reference 2760052, Essen
Site reference 2760036, Göttingen
Site reference 2760053, Göttingen
Site reference 2760054, Hanover
Site reference 2760055, Leipzig
Site reference 2760047, Potsdam
Site reference 2760039, Würzburg
Site reference 3760005, Haifa
Site reference 3760002, Tel Aviv
Site reference 3800026, Chieti
Site reference 3800027, Florence
Site reference 3800028, Genova
Site reference 3800031, Milan
Site reference 3800035, Roma
Site reference 3800036, Roma
Site reference 3800030, Rozzano
Site reference 3800037, Torino
Site reference 3920038, Chiba
Site reference 3920061, Kanagawa
Site reference 3920045, Matsumoto
Site reference 3920058, Osaka
Site reference 3920037, Saitama
Site reference 3920034, Tokushima
Site reference 3920032, Tokyo
Site reference 3920035, Yamaguchi
Site reference 5280001, Amsterdam
Site reference 5280005, Maastricht
Site reference 5280004, Utrecht
Site reference 7240010, Barcelona
Site reference 7240011, Barcelona
Site reference 7240013, Madrid
Site reference 7240014, Madrid
Site reference 7240016, Seville
Site reference 8260019, London
Site Reference 1240048, Vancouver
Site Reference 1240051, Montreal
Site Reference 3920040, Aomori
Site Reference 3920042, Aomori
Site Reference 3920065, Tokyo
Site Reference 3920062, Tokyo
Site Reference 6160058, Gdansk
Site Reference 6160060, Lodz
Site Reference 6160055, Lublin
Site Reference 8260032, Manchester
Lead Sponsor
Collaborators (1)
ICON Clinical Research
INDUSTRY
CSL Behring
INDUSTRY