7 results
Primary Objective: • Evaluate the treatment effect of NGM282 as measured by the mean change in alkaline phosphatase (ALP) from Baseline to Week 12 in patients with PSC.Secondary Objectives:• Assess the safety and tolerability of NGM282 in patients…
The primary objective of this study is:• To evaluate whether simtuzumab (formally referred to as GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.The secondary objectives of this study include the following…
To investigate feasibility, safety, and effectiveness of covered expandable stents with a proximal lasso to resolve benign post-surgical strictures.
To proof feasibility and safety of direct SEMS placement for palliative treatment of perihilar cholangiocarcinoma.
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…
To evaluate the efficacy of two doses of norucholic acid vs. placebo for the treatment of primary biliary cholangitis (PBC) in patients with an inadequate response to ursodeoxycholic acid (UDCA).
Primary objective: 1. Determine difference in stone expulsion rate with -and without Tamsulosin Secondary objectives: 1. Time to stone expulsion2. Stone expulsion rate in patients with cholangitis with -and without Tamsulosin3. Adverse events 4.…