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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2024
  • participants needed
    156
  • sponsor
    Nanjing Chia-tai Tianqing Pharmaceutical
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Updated on 16 September 2023
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Summary

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with (primary biliary cholangitis)PBC.

The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with PBC.

Details
Condition Primary Biliary Cholangitis
Treatment Placebo, UDCA, Obeticholic Acid Tablets（OCA）
Clinical Study IdentifierNCT05450887
SponsorNanjing Chia-tai Tianqing Pharmaceutical
Last Modified on16 September 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥18 and ≤75 years；
Definite PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: ① Indicators reflecting cholestasis such as elevated ALP；② Positive antimitochondrial antibody (AMA) or AMA-M2, or positive PBC-specific antibody (anti-GP210 and/or anti-SP100) if AMA negative；③ Liver biopsy consistent with PBC；
At least 1 of the following qualifying biochemistry values: ① ALP ≥ 1.67x ULN ；② Total bilirubin > ULN but < 2x ULN；
Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0；
Understand the study, comply with the study protocol, and voluntarily sign the informed consent form

Exclusion Criteria

Patients who took obeticholic acid within 3 months prior to Day 0
Known hypersensitivity to obeticholic acid, ursodeoxycholic acid
History or presence of other concomitant liver diseases
Cirrhosis-related complications or end-stage liver disease manifestations
Serum creatinine (Cr) ≥ 1.5 × ULN and serum creatinine clearance < 60 mL/min
Patients with severe pruritus or requiring systemic drug therapy within 2 months prior to Day 0
Patients with HIV or syphilis infection
Presence of diseases or physiological conditions that interfere with the absorption, distribution, metabolism or excretion of test drugs, such as inflammatory bowel disease and previous gastric bypass surgery
Presence of diseases that may cause non-hepatogenic ALP elevation, or diseases that may lead to a life expectancy of less than 2 years
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.)
Administration of the following drugs within 12 months prior to Day 0: antibodies or immunotherapy against interleukins or other cytokines or chemokines
Patients with serious cardiovascular system, digestive system, respiratory system, urinary system, nervous system, mental illness, immunodeficiency disease, and judge by investigators that they are not suitable for participating in the trial
Other conditions that are not considered appropriate by the investigator
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