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

Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Age Range:18 - 85
Start Date:June 22, 2018
End Date:June 1, 2020
Contact:Sahar Roshan

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A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the PK and
safety of OCA treatment in patients with primary biliary cholangitis (PBC) and moderate to
severe hepatic impairment over a 48 week treatment period. Patients who have completed their
48-week double blind treatment period will continue double-blind treatment until all
randomized patients have completed their 48-week treatment period and the database for that
period is locked. An open-label extension study in which all patients receive OCA will be
considered following review of blinded safety and PK data.

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

- 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
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