Status:
TERMINATED
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
Lead Sponsor:
Intercept Pharmaceuticals
Conditions:
Liver Cirrhosis, Biliary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis...
Detailed Description
This Phase 4, double-blind, randomized, placebo-controlled, multicenter study is being undertaken at up to 170 sites internationally to evaluate the effect of OCA on clinical outcomes in 428 participa...
Eligibility Criteria
Inclusion
- Key
- 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
- A mean total bilirubin \>ULN and ≤5x ULN and/or a mean ALP \>3x ULN
- 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
- 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
- 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)
- Mean total bilirubin \>5x ULN
- Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
- Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
- If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Known history of human immunodeficiency virus infection
- Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
- Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
- History of alcohol abuse or other substance abuse within 1 year prior to Day 0
- 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
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
- History of known or suspected clinically significant hypersensitivity to OCA or any of its components
- UDCA naïve (unless contraindicated)
Key Trial Info
Start Date :
December 26 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2021
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT02308111
Start Date
December 26 2014
End Date
December 23 2021
Last Update
March 9 2023
Active Locations (181)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Inland Empire Liver Foundation
Rialto, California, United States, 92377
4
University of California Davis, Davis Medical Center
Sacramento, California, United States, 95817