Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Inclusion Criteria:

1. Male or female aged 18 to 75 years.
2. Meet at least 2 of the following 3 PBC diagnoses:
3. Patients had elevated alkaline phosphatase for at least 3 months beforeenrolment.
4. AMA positive (titer ≥1:40), or if AMA negative, PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or AMA-M2) are required.
5. Liver biopsy suggested PBC 48 weeks before enrollment.
6. ALP > 1.67× ULN before enrollment.
7. Taking UDCA with stable dose for at least 3 months before enrollment.

Exclusion Criteria:

1. Merging with other virus infected.
2. With other existing liver disease or a history of liver disease.
3. With clinical complications of PBC or clinically significant hepatic decompensation.
4. Child-pugh grade B or C.
5. Creatinine (Cr) ≥ 1.5×ULN and serum creatinine clearance rate < 60mL/min; [Calculationformula: Cr:(140-age)×weight(kg) /0.818 × Scr (μmol/L)，female Cr=Cr × 0.85].
6. ALT or AST>5×ULN;Tbil > 2×ULN.
7. Patients with a history of severe pruritus 2 months before enrollment.
8. The presence of clinically relevant arrhythmias or associated history that may affectsurvival during the study period.
9. With diseases that may cause nonhepatic ALP increases (e.g., Paget's disease) or whichmay diminish life expectancy to < 2 years.