6 results
Primary objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…
Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…
Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…
Primary Objective(s)Phase I (completed)The primary objective of the Phase I portion of the study is to determine the maximum tolerated dose (MTD) of the combination of melflufen and dexamethasone in patients with relapsed/refractory multiple myeloma…
Primary for Platform-Level Exploratory Analysis1. To evaluate whether treatment with IL-23 inhibitors is superior to adult placebo in achieving clinical remission and endoscopic response in pediatric participants with moderately to severely active…
Objectives• To evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn*s disease• To assess the overall safety of guselkumabPrimary EndpointThe primary endpoint of this study is the proportion of participants who achieve combined…