7 results
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…
To demonstrate a sustained effect of odevixibat on pruritus in patients with ALGS who have completed study A4250-012 (ASSERT)
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…
ObjectivesPrimary · In Part 1 of the study is to determine the maximum tolerated doses (MTDs) and/or recommended Phase 2 dose (RP2D) of CC-220 as monotherapy (MonoT), in combination with dexamethasone (DEX) (DoubleT), in combination with DEX and…
Primary objective:To compare the efficacy of iberdomide, daratumumab and dexamethasone (IberDd) to that of daratumumab, bortezomib and dexamethasone (DVd) in terms of progression-free survival (PFS) in subjects with RRMMSecondary objectives:• In…
Primary objectivesTo evaluate the efficacy (rate of improvement in response from PR to >= VGPR; from VGPR to >=CR; from CR to sCR) of three different dose levelsof Iberdomide in maintenance treatment after ASCTSecondary objectivesTo…
The primary objective is to compare the efficacy of DVRd followed by cilta-cel and lenalidomide therapy versus DVRd followed by ASCT, DVRd consolidation, and lenalidomide therapy, in terms of progression-free survival (PFS) and sustained minimal…