Last updated on June 2020

Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary biliary cirrhosis | Primary Biliary Cholangitis
  • Age: Between 18 - 85 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases [AASLD] and European Association for the Study of the Liver [EASL] Practice Guidelines [Lindor 2009, EASL 2009]), defined as having 2 of the following 3 diagnostic factors:
    • History of elevated ALP levels for at least 6 months
    • Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (1:80), PBC specific antibodies (anti-GP210 and/or anti-SP100) and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex)
    • Liver biopsy consistent with PBC (collected at any time prior to Screening)
  2. Evidence of cirrhosis including at least one of the following:
    • Biopsy results consistent with PBC Stage 4
    • Liver stiffness as assessed by Transient Elastography (TE) Median Value 16.9kPa
    • Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly)
    • Combined low platelet count (<140 000/mm3) with
    • persistent decrease in serum albumin, or
    • elevation in prothrombin time /INR (not due to antithrombotic agent use), or
    • elevated bilirubin (2 ULN)
  3. Satisfy the criteria of the modified CP classification for hepatic impairment during
    • Moderate: CP-B (Scores 7 to 9) or
    • Severe: CP-C (Scores 10 to 12)
  4. MELD score of 6 to 24 at Screening
  5. Taking UDCA for at least 12 months (stable dose for 3 months) prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for 3 months)

Exclusion Criteria:

  1. Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
  2. History of liver transplant or organ transplant
  3. History of alcohol or drug abuse within 12 months prior to Screening
  4. Hepatic encephalopathy (as defined by a West Haven score of 2 [AASLD, EASL 2014])
  5. History or presence of other concomitant liver diseases including:
    • Hepatitis C virus infection and RNA positive
    • Active hepatitis B infection; however, patients who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
    • Primary sclerosing cholangitis
    • Alcoholic liver disease
    • Definite autoimmune liver disease or overlap hepatitis
    • Gilbert's Syndrome
  6. In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic function prior to randomization

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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