A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
Condition: Liver Fibrosis; Hepatic Fibrosis; Liver Cirrhosis; Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Intervention: IDN-6556; Placebo
Intervention description: Placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver transplant; hepatitis C; liver fibrosis; hepatic fibrosis; liver cirrhosis; hepatic cirrhosis

Summary:

      This is a double-blind, multicenter study involving patients with chronic HCV infection who
      had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete
      cirrhosis; achieved a sustained virologic response (SVR) following anti-HCV therapy; but
      still have fibrosis and/or incomplete cirrhosis on liver biopsy to see if treatment with
      IDN-6556 is better than placebo in reversing or stopping the progression of the damage to the
      new liver caused by HCV.
    

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

          -  History of orthotopic liver transplantation for HCV-induced liver disease

          -  Diagnosis of HCV infection (HCV-RNA detectable in serum) and liver fibrosis and/or
             incomplete cirrhosis status post liver transplantation, and achieved a sustained
             virologic response (SVR) with anti-viral HCV treatment within 18 months of Day 1

          -  Liver fibrosis on liver histology as read by central histopathologist of Ishak F2 to
             F6 within three months of Day 1 (Up to 15 subjects with an Ishak score of F6 can be
             enrolled)

          -  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 hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV)

          -  History of renal transplant and/or severe renal impairment defined as eGFR (estimated
             glomerular filtration rate) of less than 30 mL/min/1.73 m2

          -  Evidence of tumor burden >Milan criteria, or evidence of micro- or macrovascular
             invasion in explanted liver

          -  Hepatocellular carcinoma (HCC) at entry into the study

          -  Concurrent sirolimus (rapamycin) use

          -  History or presence of clinically concerning cardiac arrhythmias, or prolongation of
             Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)

          -  Subjects with diagnosed or suspected systemic lupus erythematosus (SLE) and/or
             rheumatoid arthritis (RA)

          -  If female: known pregnancy, positive urine or serum pregnancy test, or
             lactating/breastfeeding