4 results
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…
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…
The primary objective involves the safety of in vivo Raman/scattering during endoscopy. Therefore, we will assess safety parameters (AEs, SAEs, SUSARs). Secondary objective involves the feasibility of the probe-based scattering/(stimulated) Raman…
Primary Objective: 1) To evaluate the efficacy of DTX301 on the improvement of OTC function by maintaining safe plasma ammonia levelsSecundary Objective:1) To evaluate the efficacy of DTX301 in 3 response categories2) To evaluate the effect of…