160
Participants
Start Date
August 31, 2011
Primary Completion Date
February 28, 2015
Study Completion Date
April 30, 2015
BT086
"BT086 will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day and is calculated by the mean Immunoglobulin M (IgM) content of BT086 which is 23%.~Infusion rate:~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate) Treatment will be administered over a 5-day period."
1% Human Albumin infusion
"1% Albumin will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day.~Infusion rate:Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate). Rate is to be raised in steps of 0.1 mL every 10 min until the target infusion rate is reached.~Treatment will be administered over a 5-day period.~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate)"
401, Brussels
108, Berlin
114, Chemnitz
118, Cologne
119, Cologne
110, Dresden
111, Erfurt
116, Frankfurt
117, Greifswald
103, Halle
115, Hamburg
101, Hanover
107, Homburg/Saar
109, Lübeck
106, Marburg
120, Stuttgart
105, Tübingen
113, Wuppertal
213, Badalona
201, Barcelona
206, Barcelona
204, Girona
207, Madrid
208, Mataró
210, Palma de Mallorca
212, Sabadell
209, Santiago de Compostela
205, Tarragona
211, Terrassa
203, Valencia
303, Cardiff
304, Kings Lynn, Norfolk
301, London
306, London
302, Poole, Dorset
305, Reading, Berkshire
Lead Sponsor
Biotest
INDUSTRY