Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements
Is an adult male or female, must be ≥18 years of age at the time of signing informed consent
Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA in the past 3 months prior to screening
Has documented evidence of cirrhosis and has ALP >ULN and TB ≤5 × ULN
Has consumption of 2 standard alcohol drinks per day (or 14 alcohol drinks per week) if male and 1 standard alcohol drink per day (or 7 alcohol drinks per week) if female for ≥3 consecutive months (12 consecutive weeks) within 5 years prior to screening
Has known CPT B (having a score of ≥7) or CPT C (having a score of ≥10) cirrhosis classification at screening
Has a Model for End-Stage Liver Disease (MELD)-Na score of ≥12 at screening
Use of the following medications (within 12 weeks prior to screening until the randomization [Day 1] visit): thiazolidinediones, fibrates, OCA, methotrexate, budesonide, and other systemic corticosteroids (equivalent to prednisone dose >10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, and nitrofurantoin); any other newly approved treatments for PBC (eg, elafibranor, seladelpar)