1. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment) 
2. AST or ALT > 3 × ULN 
3. Total bilirubin > 2 × ULN 
4. Auto-immune hepatitis 
5. Primary sclerosing cholangitis 
6. Known history of alpha-1-Antitrypsin deficiency 
7. Known history of chronic viral hepatitis 
8. Creatine kinase above ULN 
9. Serum creatinine above ULN 
10. For females, pregnancy or breast-feeding 
11. Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening 
12. Current use of fibrates, including fenofibrates, or simvastatin 
13. Use of an experimental treatment for PBC 
14. Use of experimental or unapproved immunosuppressant 
15. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator       
    

NCT02609048_exc_T16
Condition
medical condition
NCT02609048_exc_T17
Condition
PBC
NCT02609048_exc_T18
Negation
other than
NCT02609048_exc_T22
Measurement
AST
NCT02609048_exc_T23
Measurement
ALT
NCT02609048_exc_T24
Value
> 3 × ULN
NCT02609048_exc_T25
Measurement
Total bilirubin
NCT02609048_exc_T26
Value
> 2 × ULN
NCT02609048_exc_T27
Condition
Auto-immune hepatitis
NCT02609048_exc_T28
Condition
Primary sclerosing cholangitis
NCT02609048_exc_T29
Condition
alpha-1-Antitrypsin deficiency
NCT02609048_exc_T30
Observation
history
NCT02609048_exc_T31
Condition
viral hepatitis
NCT02609048_exc_T32
Temporal
chronic
NCT02609048_exc_T33
Observation
history
NCT02609048_exc_T34
Measurement
Creatine kinase
NCT02609048_exc_T35
Value
above ULN
NCT02609048_exc_T36
Measurement
Serum creatinine
NCT02609048_exc_T37
Value
above ULN
NCT02609048_exc_T38
Person
females
NCT02609048_exc_T39
Condition
pregnancy
NCT02609048_exc_T40
Condition
breast-feeding
NCT02609048_exc_T41
Scope
pregnancy or breast-feeding
NCT02609048_exc_T42
Drug
colchicine
NCT02609048_exc_T43
Drug
methotrexate
NCT02609048_exc_T44
Drug
azathioprine
NCT02609048_exc_T45
Drug
systemic steroids
NCT02609048_exc_T46
Temporal
in the two months preceding screening
NCT02609048_exc_T47
Reference_point
screening
NCT02609048_exc_T48
Scope
colchicine, methotrexate, azathioprine, or systemic steroids
NCT02609048_exc_T49
Drug
fibrates
NCT02609048_exc_T50
Temporal
Current
NCT02609048_exc_T51
Drug
fenofibrates
NCT02609048_exc_T52
Drug
simvastatin
NCT02609048_exc_T53
Scope
fibrates, including fenofibrates, or simvastatin
NCT02609048_exc_T55
Procedure
experimental treatment for PBC
NCT02609048_exc_T57
Drug
immunosuppressant
NCT02609048_exc_T58
Qualifier
unapproved
NCT02609048_exc_T59
Qualifier
experimental
NCT02609048_exc_T60
Scope
experimental or unapproved