Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

Exclusion Criteria

• •A patient will be excluded from the study if any of the following criteria are met:
• •Presence of Child-Pugh Class C decompensated cirrhosis at screening;
• •Itching secondary to biliary obstruction;
• •History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis;
• •Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15;
• •Alanine aminotransferase or aspartate aminotransferase \>5 × upper limit of normal at screening, or within 2 months prior to screening;
• •Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period;
• •New or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.