A Study of IDN-6556 in Subjects With Liver Cirrhosis
LC
A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in Subjects With Liver Cirrhosis
1 other identifier
interventional
87
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
July 5, 2017
CompletedJuly 5, 2017
June 1, 2017
1.4 years
August 28, 2014
January 27, 2017
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline at Month 3 in cCK18/M30
Baseline, Month 3, and change between for cCK18/M30
3 months
Change From Baseline at Month 3 in cCK18/M30
Data was log-transformed for analysis purposes
3 months
Secondary Outcomes (1)
Change From Baseline to Month 3 in MELD Score
3 Months
Study Arms (2)
IDN-6556
EXPERIMENTAL25 mg BID of IDN-6556
Placebo
PLACEBO COMPARATORPlacebo BID
Interventions
Eligibility Criteria
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:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Scripps Clinic
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Cedar-Sinai Medical Center
Los Angeles, California, 90048, United States
Univeristy of California, San Diego
San Diego, California, 92093, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33136, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
University of Chicago
Chicago, Illinois, 60637, United States
Loyola University Medical Cente
Maywood, Illinois, 60153, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
NYU Medical Center
New York, New York, 10016, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, 45267, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
UT Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Bon Secours Mary Immaculate Hospital
Newport News, Virginia, 23602, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, 23226, United States
Related Publications (1)
Frenette CT, Morelli G, Shiffman ML, Frederick RT, Rubin RA, Fallon MB, Cheng JT, Cave M, Khaderi SA, Massoud O, Pyrsopoulos N, Park JS, Robinson JM, Yamashita M, Spada AP, Chan JL, Hagerty DT. Emricasan Improves Liver Function in Patients With Cirrhosis and High Model for End-Stage Liver Disease Scores Compared With Placebo. Clin Gastroenterol Hepatol. 2019 Mar;17(4):774-783.e4. doi: 10.1016/j.cgh.2018.06.012. Epub 2018 Jun 18.
PMID: 29913280DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jean L. Chan, MD
- Organization
- Conatus Pharmaceuticals
Study Officials
- STUDY CHAIR
Dave Hagerty, MD
Conatus Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 3, 2014
Study Start
August 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 5, 2017
Results First Posted
July 5, 2017
Record last verified: 2017-06