Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets all of the following conditions
* Definite or probable PBC as defined by at least 2 of the 3 following criteria:
* Serum alkaline phosphatase (ALP) \> the upper limit of normal (ULN)
* Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on immunofluorescence)
* Liver histological findings consistent with PBC including nonsuppurative, destructive cholangitis affecting mainly the interlobular bile and septal bile ducts
* Serum ALP \> 1.67 x ULN and/or total bilirubin \>ULN but ≤ 2 x ULN
* Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or intolerant of UDCA with no UDCA use for at least 12 months before screening
Screening FibroSURE/FibroTest® \< 0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest will be calculated using direct bilirubin instead of total bilirubin.
You may not be if
Alanine aminotransferase (ALT) \> 5 x ULN
Total bilirubin \> 2 x ULN
International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
Other causes of liver disease including viral, metabolic, alcoholic, and other autoimmune conditions. Participants with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy.
Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment
Cirrhosis of the liver as defined by any of the following:
* Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)
* History of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
