3 results
This non-controlled multicentric phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase for first-line treatment of infants (< 1 year of age at…
- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…
This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…