8 results
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
Primary Objective:To demonstrate the efficacy of repeated daily doses of 120 µg/kg/day odevixibat in relieving pruritus in patients with ALGS.Secondary Objectives:To assess the impact of odevixibat on serum bile acid levels in patients with ALGS.To…
The primary objective of the present study is to explore the safety and feasibility of electrical stimulation in patients with diverse kinds of nerve lesions. The secondary objective is to make a reasonable estimation of clinical effect size, which…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
Primary Objective:The primary objective is to evaluate the efficacy of repeated once-daily doses of odevixibat versus placebo in children with biliary atresia (BA) post Kasai hepatoportoenterostomy(HPE) based native liver survival (NLS) of up to 104…
To demonstrate a sustained effect of odevixibat on pruritus in patients with ALGS who have completed study A4250-012 (ASSERT)
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…