6 results
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…
Key PrimaryPart A• To determine the efficacy of acoramidis (AG10) in the treatment of subjects with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) by evaluating the difference between the acoramidis and placebo groups in the change from…
Primary• To assess safety and tolerability of acoramidis in participants with symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM)Secondary• To evaluate the effect of acoramidis on all-cause mortality and cardiovascular (CV) mortality• To…
Primary ObjectiveTo evaluate the preliminary safety and tolerability and the preliminary efficacy of cobimetinib administered as single agent (Arm A), cobimetinib + venetoclax (Arm B), and cobimetinib + venetoclax + atezolizumab (Arm C)Secondary…
Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…
Primary:To determine the efficacy of AG10 in the treatment of subjects with symptomatic transthyretin amyloid polyneuropathy (ATTR-PN) by evaluating the difference between the AG10 and placebo groups in Modified Neuropathy Impairment Score + 7 (mNIS…