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In cholestatic liver disease such as primary biliary cholangitis (PBC), ileal bile acid absorption is increased and might lead to pruritus. Therefore, inhibiting bile acid transport is being explored as a therapeutic strategy.
In an industry-sponsored, double-blind, phase IIA trial, researchers tested the safety and efficacy of an ileal bile acid transporter inhibitor, GSK2330672. After a 2-week, open placebo run-in phase, 22 patients were randomized to receive oral GSK2330672 or placebo twice daily for 14 days. Participants were then crossed over to the other study arm for another 14 days, followed by a 14-day blinded treatment with placebo. The primary endpoint was safety, and the secondary endpoint was change in pruritus, based on validat…