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Protocol 747-302
Title Double Blind, Randomized, Placebo-Controlled, Mulicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis
Phase III
Area Liver
Indication

Primary Biliary Cirrhosis
Treatment

Obeticholic Acid or Placebo
Requirement

1.  Definite or probable PBC diagnosis (consistent with AASLD and EASL practice
guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥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 in 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
2.  A mean total bilirubin >ULN and ≤3x ULN or an ALP >5x ULN
3.  Age ≥18 years
4.  Either is not taking UDCA (UDCA naïve or no UDCA dose in the past 3 months) or
has been taking UDCA for at least 12 months with an approved, stable dose for
≥3 months prior to Day 0
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