Clinical Trials

Inclusion Criteria:

• Completed both Treatment Period 1 and Treatment Period 2 (Year 1 and Year 2) of the CENTAUR study (652-2-203), including a Year 2 liver biopsy.
• Completed the AURORA study and who reached an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
  • o Histopathologic progression to cirrhosis;
  • o MELD score ≥ 15;
  • o Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic);
  • o Hospitalization (as defined by a stay of ≥ 24 hours) for onset of: variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).
• Has been determined to be in a stable medical condition (minimum of approximately months from the date of the clinical event in AURORA to the Baseline Visit of this study) based on medical history or physical examination, in the opinion of investigator.  Inclusion criterion applies only to subjects coming from the AURORA study (3152-301-002).
• Provided a signed written informed consent form.
• Females of child-bearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥ 12 months without an alternative medical cause. Follicle stimulating hormone (FSH) level in the postmenopausal range (≥ 30 mU/mL) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
  • a) Females on HRT and whose menopausal status is in doubt will be required to use the contraception methods in Section 20.3 if they wish to continue their HRT during the study. Otherwise, they must temporarily discontinue HRT to enable confirmation of postmenopausal status before study enrollment.

Exclusion Criteria:

• Any clinically significant change in the subject’s medical history or condition which, in the opinion of the investigator, would preclude administration of open-label CVC, including laboratory tests.
• Prior or planned liver transplantation.
• Other known causes of chronic liver disease, such as the following:
  • Alcoholic liver disease;
  • Primary biliary cirrhosis;
  • Primary sclerosing cholangitis;
  • Autoimmune hepatitis;
  • Wilson’s disease, hemochromatosis, or iron overload;
  • Alpha-1 antitrypsin (A1AT) deficiency.
• Females who are pregnant or breastfeeding.
• Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements.
• Currently receiving or planning to use any other investigational NASH treatment during the study.
• Known history of hepatocellular carcinoma (HCC) at any time, history of malignancy within the past 5 years or ongoing malignancy other than: basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated stage II or lower colorectal or breast cancer in remission for ≥ 2 years and with low risk of recurrence (ie, Oncotype DX 12 gene recurrence score < 30 for stage II or lower colon cancer; early-stage, estrogenreceptor positive, HER2-negative breast cancers that haven’t spread to the lymph nodes; Oncotype DX 21 gene recurrence score < 18 for early-stage invasive breast cancer; or Oncotype DX ductal carcinoma in situ [DCIS] 12 gene recurrence score < 39 for noninvasive breast cancer).