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520A AASLD ABSTRACTS HEPATOLOGY, October, 2015 trolled studies (2 Phase 2 trials and 1 Phase 3). Abnormal bilirubin was not a common feature in the individual studies, therefore, data from all three studies was pooled; since all studies included a 3-month point, integrated data was evaluated at 3 months. ALP was markedly elevated at baseline in patients with abnormal bilirubin and OCA treatment was associated with significant ALP reductions. Mean bilirubin levels increased in the placebo arm and decreased with OCA, although the difference was not statistically significant over this short 3-month timeframe. Further evaluation of a subset of subjects treated to 12 months showed a significant reduction vs. placebo (Mean±SE:-8.9±2.2 vs -0.7±1.7; p
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 521A 28d with no exclusions for severity or treatment of PRU. Patients were stratified by presence of prurius (PRU) at BL using the 5-D Itch Scale (5D). PRU was measured by Visual Analogue Scale (VAS) and the 5D at BL and Days 14, 28 and 42. Subjects with a BL and Day 28 VAS (n=38) and/or 5D (n=41) were categorized as improved, no change or worsened based on a >20% change from BL at Day 28. Correlations between PRU and liver chemistries or serum BAs by VAS were assessed by Spearman correlation and regression analyses with a clinical anchor threshold of r >0.30 and p
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1000A AASLD ABSTRACTS HEPATOLOGY, O
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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