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. 2024 Mar 22;80(5):1291–1300. doi: 10.1097/HEP.0000000000000864

TABLE 1A.

Baseline alkaline phosphatase values for key phase 2 and 3 trials in PBC

Trial agent Mean baseline ALP Mean baseline ALP:ULN ratio
OCA phase 224 287±164 2.2
OCA phase 3 (“POISE”)16 326±196 2.5
OCA phase 3 confirmatory (“COBALT”)25 490±285 3.8
Bezafibrate phase 317 243±114 1.8
Elafibranor phase 3 (“ELATIVE”)21 322±151 3.1
Seladelpar phase 3 (“ENHANCE”)20 292±171 2.3
Budesonide phase 226 341±182 2.6

Abbreviation: ALP, alkaline phosphatase.