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A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV (POLT-HCV-SVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138253
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Hepatic Fibrosis Liver Cirrhosis Hepatic Cirrhosis Drug: IDN-6556 Drug: Placebo Phase 2

Detailed Description:
There are data to suggest that with eradication of the HCV virus, improvements in liver fibrosis can be seen in the post-transplant population. However, amelioration of inflammatory activity, and deceleration of fibrosis progression is a gradual process over the course of many years. This placebo-controlled study is designed to evaluate the effects of IDN-6556, compared to placebo, on markers of apoptosis and inflammation, and liver histology.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects Who Had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis Following Orthotopic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following Anti-HCV Therapy
Study Start Date : May 2014
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDN-6556
IDN-6556 25 mg BID
Drug: IDN-6556
Other Names:
  • emricasan
  • PF-03491390

Placebo Comparator: Placebo
Placebo BID
Drug: Placebo
Placebo control




Primary Outcome Measures :
  1. Ishak Fibrosis Score [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Necro-inflammatory sub-score of the modified Histological Activity Index [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138253


  Hide Study Locations
Locations
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United States, California
Southern California Research Center
Coronado, California, United States, 92118
Scripps Clinic
La Jolla, California, United States, 92037
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
UCLA Pfleger Liver Institute
Los Angeles, California, United States, 90095
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Johns Hopkins Sibley Memorial Hospital
Washington, District of Columbia, United States, 21287
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Health Science Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henery Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
University of Pennsylvania Milton Hershey Hospital
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Baylor All Saints Medical Center
Fort Worth, Texas, United States, 76104
Liver Associates of Texas, PA
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
VAMC/Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Bon Secours Mary Immaculate Hospital
Newport News, Virginia, United States, 23602
Bon Secours St. Mary's Hospital of Richmond
Richmond, Virginia, United States, 23226
McGuire DVAMC
Richmond, Virginia, United States, 23249
United States, Washington
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
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Study Chair: David Hagerty, MD Conatus Pharmaceuticals

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Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02138253     History of Changes
Other Study ID Numbers: IDN-6556-07
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by Conatus Pharmaceuticals Inc.:
liver transplant
hepatitis C
liver fibrosis
hepatic fibrosis
liver cirrhosis
hepatic cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics