Please assess the completion status of the following clinical trial:

Trial Title: Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: QUADRUPLE
- Phase: PHASE4
- Number of Arms: 2.0

Eligibility Criteria:
Key Inclusion Criteria:~1. Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases \[AASLD\] and the European Association for the Study of the Liver \[EASL\] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:~   * History of elevated Alkaline phosphatase 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 ≤5x ULN and/or a mean ALP \>3x ULN~3. Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0~Exclusion Criteria:~1. History or presence of other concomitant liver diseases including:~   * Hepatitis C virus infection~  * Active Hepatitis B infection; however, subjects 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 (PSC)~  * Alcoholic liver disease~  * Definite autoimmune liver disease or overlap hepatitis~  * Nonalcoholic steatohepatitis (NASH)~  * Gilbert's Syndrome~2. Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:~   * History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score \>12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria~  * Cirrhosis with complications, including history (within the past 12 months) or presence of:~     * Variceal bleed~    * Uncontrolled ascites~    * Encephalopathy~    * Spontaneous bacterial peritonitis~  * Known or suspected HCC~  * Prior transjugular intrahepatic portosystemic shunt procedure~  * Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine \>2 mg/dL (178 μmol/L)~3. Mean total bilirubin \>5x ULN~4. Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures~5. Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)~6. If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating~7. Known history of human immunodeficiency virus infection~8. Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)~9. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study~10. History of alcohol abuse or other substance abuse within 1 year prior to Day 0~11. Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study~12. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain~13. History of known or suspected clinically significant hypersensitivity to OCA or any of its components~14. UDCA naïve (unless contraindicated)

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Obeticholic Acid (OCA) 5 mg to 10 mg (Type: EXPERIMENTAL): Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).
- Placebo (Type: PLACEBO_COMPARATOR): None

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: enrollment issues