5 results
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 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…
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 generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…
Primary objectives: The first primary objective is to study the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate the pretreatment 89Zr-…