Halo Pharmaceutical Canada, Inc.

Primary objective: Based on the primary endpoint, to evaluate the efficacy of Volixibat compared with placebo in the treatment of pruritus in PBC subjects; Secondary objective: Based on the secondary endpoint, to evaluate the efficacy of Volixibat compared with placebo in improving cholestasis markers in PBC subjects.

The primary objective was to evaluate the effectiveness of maralixibat for biliary drainage after hepatoportoenterostomy (HPE) in patients with biliary atresia (BA). Secondary objectives were to evaluate changes in sBA (serum bile acid) levels after maralixibat treatment, to evaluate the rate of bilirubin normalization after maralixibat treatment, to evaluate transplant-free survival after maralixibat treatment, to evaluate biochemical markers of cholestasis and liver disease after maralixibat treatment, and to evaluate the safety, tolerability, and pharmacokinetics of maralixibat.