5 results
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)
This study has multiple purposes:Primary objective:1: to investigate whether it is possible to identify the small mimic muscles independently of each other and to determine the exact position of the origin and insertion of the mimic muscles on 7…
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…
Primary Objective:* confirm the dose of nomacopan and sample size for Part B and evaluate the rank order of secondary endpointsOther Objectives:* compare nomacopan with adjunct OCS to placebo with adjunct OCS in achievement of Complete Remission of…