CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

Prior treatment

• OCA(Obercholic acid) in the 3 months prior to randomization
• Known concomitant hepatobiliary disease or history
• Severe pruritus or systemic medication was required within 2 months prior to randomization
• History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease, prior or planned (during the study period) bariatric surgery (such as gastroplasty, roux-en-Y gastric bypass).
• Concomitant use of medications, food, and drinks that are strong or moderate CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drug and throughout the study duration.
• Perazathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, and pentoxifylline were administered from 28 days before randomization to the entire clinical study period. Fenofibrate or other Bates; Budesonide and other systemic corticosteroid hormones; Hepatotoxic drugs; Liver protection Drugs and other hepatoprotective drugs were given a stable dose \<28 days before randomization or could not be maintained during the trial; cholagogue
• The administration of interleukin or other cytokine antibodies, as well as chemical factors or immunotherapy, was prohibited from 12 months prior to randomization throughout the clinical study period
• Substance abuse or alcoholism from 6 months prior to randomization throughout the entire clinical study period
• Use of other investigational drugs within 3 months

Other illness

• Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
• Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.
• Diseases that may cause non-hepatic elevation of ALP (such as Paget's disease) or may result in a life expectancy of less than 2 years
• A history of malignant tumor within 5 years prior to randomization
• Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator

Lab values

• ALT or AST\>5×ULN；
• (creatinine, Cr) ≥1.5×ULN and Cr clearance rate \<60 mL/min
• Platelet\<80×10\^9/L；
• INR\>1.3
• ALB\<3.5 g/dL
• Arrhythmia, Or during screening the QTc interval was ≥450 ms for male and 470 ms for female
• Poor blood glucose control, that is, HBA1c \>9.0% at screening

Other

• Poor blood pressure control is indicated by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening
• Pregnancy, planned pregnancy, lactation

• When signing ICF age≥18 years≤75 years, male or female
• Meets the diagnostic criteria of PBC, such as elevation ALP, positive AMA or AMA-M2, If negative for AMA, positive for PBC specific antibody and Liver biopsy meeting PBC criteria six months before screening
• 1.67 × ULN ≤ALP ≤ 10 × ULN and TBil≤ 3 × ULN
• UDCA≥6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) ≥3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization)
• Understand the study content, comply with the study protocol, and sign the ICF voluntarily
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