Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

Inclusion Criteria:

1. Age ≥18 and ≤75 years；

2. Definite PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3diagnostic factors: ① Indicators reflecting cholestasis such as elevated ALP；②Positive antimitochondrial antibody (AMA) or AMA-M2, or positive PBC-specificantibody (anti-GP210 and/or anti-SP100) if AMA negative；③ Liver biopsy consistentwith PBC；

3. At least 1 of the following qualifying biochemistry values: ① ALP ≥ 1.67x ULN ；②Total bilirubin > ULN but < 2x ULN；

4. Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, orunable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0；

5. Understand the study, comply with the study protocol, and voluntarily sign theinformed consent form.

Exclusion Criteria:

1. Patients who took obeticholic acid within 3 months prior to Day 0;

2. Known hypersensitivity to obeticholic acid, ursodeoxycholic acid;

3. History or presence of other concomitant liver diseases;

4. Cirrhosis-related complications or end-stage liver disease manifestations;

5. Serum creatinine (Cr) ≥ 1.5 × ULN and serum creatinine clearance < 60 mL/min;

6. Patients with severe pruritus or requiring systemic drug therapy within 2 monthsprior to Day 0;

7. Patients with HIV or syphilis infection;

8. Presence of diseases or physiological conditions that interfere with the absorption,distribution, metabolism or excretion of test drugs, such as inflammatory boweldisease and previous gastric bypass surgery;

9. Presence of diseases that may cause non-hepatogenic ALP elevation, or diseases thatmay lead to a life expectancy of less than 2 years;

10. Administration of the following drugs within 6 months prior to Day 0: azathioprine,colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline;fenofibrate or other fibrates; budesonide and other systemic corticosteroids;hepatotoxic drugs (including α-methyldopa, sodium valproate, isoniazid,nitrofurantoin, etc.);

11. Administration of the following drugs within 12 months prior to Day 0: antibodies orimmunotherapy against interleukins or other cytokines or chemokines;

12. Patients with serious cardiovascular system, digestive system, respiratory system,urinary system, nervous system, mental illness, immunodeficiency disease, and judgeby investigators that they are not suitable for participating in the trial;

13. Other conditions that are not considered appropriate by the investigator.