A Study of IDN-6556 in Subjects With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— LC  

Official title:

A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in Subjects With Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230670
• Other study ID #: IDN-6556-10
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2014
• Last updated: February 4, 2016
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Conatus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Numerous studies have shown that caspase cleaved cytokeratin 18 (cCK18) is elevated in the serum of liver disease patients and has been associated with disease severity, thus associating both excessive apoptosis and caspase activity with disease. Studies have also shown that caspase cleaved cytokeratin 18 is generally elevated to an even greater degree in cirrhosis than in other liver diseases. In addition, increasing stages of cirrhosis from Child-Pugh A, Child-Pugh B to Child-Pugh C are associated with progressively higher levels of caspase cleaved cytokeratin 18. Therefore, it appears that apoptosis and caspase activity tend to correlate with the stage of cirrhosis. A caspase inhibitor like IDN-6556 could have clinical utility by reducing the rate of apoptosis in cirrhotic patients and potentially reduce the progression of disease as determined by clinical markers of progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hepatic Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• IDN-6556
25 mg BID
• Placebo

Locations

Country	Name	City	State
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati Physicians Company, LLC	Cincinnati	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Baylor All Saints Medical Center	Forth Worth	Texas
United States	University of Florida	Gainsville	Florida
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	Indiana University	Indianapolis	Indiana
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	University of Louisville	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Loyola University Medical Cente	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Bon Secours Mary Immaculate Hospital	Newport News	Virginia
United States	Mt. Sinai School of Medicine	NYC	New York
United States	NYU Medical Center	NYC	New York
United States	Einstein Healthcare Network	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Bon Secours St. Mary's Hospital of Richmond, Inc.	Richmond	Virginia
United States	University of Utah Hospital	Salt Lake City	Utah
United States	Univeristy of California, San Diego	San Diego	California
United States	California Pacific Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Conatus Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cCK18	Changes in Baseline in cCK18 will be assessed	3 months	No
Secondary	MELD Score	Changes in MELD score will be assessed	3 Months	No