8 results
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
The aim of this study is to retrieve extra measurements by Nexfin and laboratory testing in the per- and postoperative period. Can the use of Nexfin contribute in the generation of meaningful data to get an idea of the hemodynamic state of the…
Primary Objective- To evaluate and compare the maintenance of effect of two doses of PF-04965842 (200 mg and 100 mg once daily [QD]) and placebo in subjects aged 12 and above with moderate to severe atopic dermatitis who respond to an initial open-…
The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery, and how this relates to postoperative complications.
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The primary objective of the study are to: 1) Determine the safety and tolerability of G1T48 alone (Parts 1 and 2) or in combination with palbociclib (Part 3), 2) Determine the MTD and RP2D of G1T48 alone (Parts 1 and 2) or in combination with…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…
Phase 1Primary ObjectivesTo assess the safety and tolerability of orally administered CLN-081 monotherapy.To define the maximum tolerated dose (MTD) of orally administered CLN-081 monotherapy.Secondary ObjectivesTo assess the anti-tumor activity.To…