Impact of Antibodies Against Polyethylene Glycol on the Pharmacokinetics of PEGylated Asparaginase in Children with Acute Lymphoblastic Leukaemia: A Population Pharmacokinetic Approach.

Christian Siebel Claudia Lanvers-KaminskyJulia AltenPetr Smisek Christa Ellen Nath Carmelo Rizzari Joachim Boos Gudrun Würthwein

Published in: European journal of drug metabolism and pharmacokinetics (2021)

Pre-existing antibodies against PEG-ASNase significantly increased the initial clearance in a subgroup of patients showing high antibody levels. (Trial registration: EU clinical trials register; EudraCT No: 2007-004270-43; first registered 23 October 2009.).

Keyphrases

clinical trial
end stage renal disease
phase iii
newly diagnosed
ejection fraction
chronic kidney disease
phase ii
peritoneal dialysis
study protocol
randomized controlled trial
patient reported outcomes