A Study of IDN-6556 in Subjects With Liver Cirrhosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis, Hepatic Cirrhosis

In brief

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.

Key facts

Study ID

NCT02230670

Run by

Conatus Pharmaceuticals Inc.

People needed

87

Starts

2014-08-01

Expected to finish

2016-01-01

Last updated by the study team

2017-07-05

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
• 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.

You may not qualify if…

• 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:
• Fibrates or statins
• 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:
• Systemic corticosteroids
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Scripps Clinic — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Cedar-Sinai Medical Center — Los Angeles, California, United States
• Univeristy of California, San Diego — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Loyola University Medical Cente — Maywood, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• NYU Medical Center — New York, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• University of Cincinnati Physicians Company, LLC — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Einstein Healthcare Network — Philadelphia, Pennsylvania, United States
• Baylor All Saints Medical Center — Fort Worth, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• UT Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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