4 results
To evaluate the efficacy of romiplostim for the treatment of thrombocytopenia in subjects with international prognostic scoring system (IPSS) low or intermediate-1 risk MDS as measured by the number of clinically significant bleeding events.
1. To investigate the safety and tolerability of single oral doses of NS11821 in healthy male subjects and estimate a maximum tolerated dose.2. To investigate the pharmacokinetics (PK) of single ascending oral doses of NS11821.
The main objective of this treatment protocol is to study the efficacy on the treatment response after adding a single gift of Mylotarg. Furthermore, monitoring of toxicity and long term efficacy is also important.
Protocol version Amendment 1, 31-Jul-2015, paragraph 2.1, page 28:Primary objective:The primary objective is to assess the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.Secondary objectives:* Evaluation of…