A Study of IDN-6556 in Subjects With Liver Cirrhosis
Condition: Liver Cirrhosis; Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: IDN-6556; Placebo
Intervention description: 25 mg BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cirrhosis; Hepatic Cirrhosis

Summary:

      This is a multicenter study to see if treatment with IDN-6556 can help improve the liver
      function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores
      between 11-18.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects of minimum adult legal age (according to local laws for
             signing the informed consent document), able to provide written informed consent, and
             able to understand and willing to comply with the requirements of the study

          -  Clinical, radiological, or biochemical evidence of liver cirrhosis

          -  Model for End-Stage Liver Disease (MELD) Score of 11 to 18 during the Screening period

          -  Willingness to utilize two reliable forms of contraception (for both males and females
             of childbearing potential) from Screening to one month after the last dose of study
             drug.

        Exclusion Criteria:

          -  Known infection with human immunodeficiency virus (HIV)

          -  Auto-immune hepatitis

          -  Subjects with evidence of uncontrolled infection, defined as persistent bacterial
             culture positivity despite adequate antibiotic therapy

          -  HCV infected subjects who are receiving or plan to receive anti-viral therapy during
             the study

          -  Untreated esophageal varices with high risk stigmata for hemorrhage

          -  Variceal hemorrhage within 3 months of Screening

          -  Ascites not adequately controlled on stable background medication

          -  Other non-liver organ failure

          -  Child-Pugh score of 10-15 (Child-Pugh C classification)

          -  Use of vasoactive drugs (at or within 3 months of Screening) that may impair hepatic
             blood flow

          -  Change in dose or regimen within 3 months of Screening of:

               1. Fibrates or statins

               2. Angiotensin II receptor antagonist or angiotensin converting enzyme (ACE)
                  inhibitor

          -  Use of chronic anticoagulation therapy including but not limited to Vitamin K/Factor
             Xa antagonists/inhibitors

          -  Use of the following drugs within 2 months of Screening:

               1. Systemic corticosteroids

               2. Known or suspected use of illicit drugs or drugs of abuse (allowed if medically
                  prescribed or indicated)

          -  Concomitant pancreatitis

          -  Active inflammatory bowel disease

          -  Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis
             (RA)

          -  Subjects with active or history of malignancies other than hepatocellular carcinoma
             (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous
             cell carcinomas), unless adequately treated or in complete remission for five or more
             years