Intercept study in cirrhotic NASH patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants are older than 18 years of age
    2. Participants have a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading of a liver biopsy obtained no more than 12 months before Day 1
    3. Female subjects of childbearing potential must use =1 effective method (=1% failure rate) of contraception during the study until 4 weeks following the last dose of investigational product (including OLE doses)
    4. Participants must provide written informed consent and agree to comply with the study protocol

You may not be eligible for this study if the following are true:

    1. Participants who have current or past history of hepatic decompensation such as clinically significant ascites (requiring medical intervention), variceal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy (Grade I or greater based on West Haven classification), or hepatorenal/hepatopulmonary syndromes
    2. Participants who have current or past history of hepatic function impairment with CP score =7 points
    3. Participants whose MELD score >12
    4. Participants who were hospitalized within 1 year of Day 1 for complications of cirrhosis
    5. Participants who have documented presence of varices based on prior endoscopy performed within 6 months of Day 1
    6. Participants who have a AST =5× upper limit of normal (ULN)
    7. Participants who have a ALT =5× ULN
    8. Participants whose calculated creatinine clearance <60 mL/min using Cockcroft-Gault method at Screening
    9. Participants who have a Platelet count =100000100 000/mm3 at Screening
    10. Participants who have total bilirubin >2 mg/dL (subjects with an established diagnosis of Gilbert’s syndrome and a normal hemoglobin and reticulocyte count may be enrolled despite a total bilirubin level >2 mg/dL if their conjugated (direct) bilirubin is <2x ULN)
    11. Participants who have Conjugated bilirubin =1.5x ULN
    12. Participants who have Albumin <3.25 g/dL.
    13. Participants who have International normalized ratio (INR) =1.7 (subjects with a known inherited blood disorder and INR =1.7 may be enrolled, and subjects on anticoagulant/antiaggregantanti-aggregant treatment and INR =1.7 may be enrolled by approval of Medical Monitor)
    14. Participants who have current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before Day 1 (significant alcohol consumption is defined as more than 2 units/day for females and more than 4 units/day for males, on average)
    15. Participants who have prior (at any point) or planned (during the study period) ileal resection, or prior (within 5 years before Screening) or planned (during the study period) bariatric surgery (eg, gastric bands, gastroplasty, roux-en-Y gastric bypass)
    16. Participants who have the inability to safely undergo a liver biopsy
    17. Participants who have a history of biliary diversion
    18. Participants who have evidence of other known forms of chronic liver disease.
    19. Participants who have history of liver transplant, current placement on a liver transplant list
    20. Participants who have hemoglobin A1c =9.5% within 60 days before Day 1.
    21. Participants who have low-density lipoprotein (LDL) cholesterol =190 mg/dL and already on a stable dose of statin and/or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for =30days at Screening.
    22. Participants who have LDL cholesterol <50 mg/dL
    23. Participants who have known positivity for human immunodeficiency virus infection
    24. Participants with recent history (within 1 year of Day 1) of significant atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, acute coronary syndrome, cerebrovascular accident [stroke], cerebrovascular ischemia, transient ischemic attack, or peripheral vascular disease requiring intervention).
    25. Participants with current acute cholecystitis or acute biliary obstruction
    26. Participants with other medical conditions that may diminish life expectancy to <2years, including known cancers
    27. Participants with known substance abuse in the year before Screening
    28. Participants who have chronic use (=12 months) of drugs historically associated with drug-induced NAFLD within the 5 years before Day 1 (eg, amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).
    29. Participants with pregnancy, planned pregnancy, potential for pregnancy (ie, unwillingness to use effective birth control during the study), or current or planned breast feeding
    30. Participants who have participated in a clinical research study and received any active investigational product being evaluated for the treatment of diabetes, weight loss, or NASH in the 6 months before Day 1
    31. Participants who have concurrent participation in any other interventional or noninterventional clinical trial.
    32. Participants who have received any investigational product from Screening to Day 1, within 30 days before Day 1, or within 5 half-lives of the compound (whichever was longer) before Day 1
    33. Participants who with previous exposure to OCA within 12 months of Day 1
    34. Participants who have mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study, is uncertain
    35. Participants who have history of known or suspected clinically significant hypersensitivity to OCA or any of its components
    36. Participants who have any other condition that, in the opinion of the Investigator, might confound the results, or would impede compliance or hinder completion of the study