A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV

Completed · Phase 2 · Has a placebo group

Conditions studied: Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis

In brief

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.

Key facts

Study ID

NCT02138253

Run by

Conatus Pharmaceuticals Inc.

People needed

64

Starts

2014-05-01

Expected to finish

2018-03-09

Last updated by the study team

2019-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southern California Research Center — Coronado, California, United States
• Scripps Clinic — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• UCLA Pfleger Liver Institute — Los Angeles, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane Health Science Center — New Orleans, Louisiana, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• John Hopkins Hospital — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henery Ford Health System — Detroit, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• University of Cincinnati Physicians Company — Cincinnati, Ohio, United States
• University of Pennsylvania Milton Hershey Hospital — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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