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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:May 2014
End Date:March 9, 2018

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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

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.

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.

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
We found this trial at
35
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Atlanta, Georgia 30309
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Baltimore, Maryland 21287
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Chicago, Illinois 60637
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Coronado, California 92118
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Detroit, Michigan 48202
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Fort Worth, Texas 76104
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Houston, Texas 77030
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Houston, Texas 77030
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Los Angeles, California 90095
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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New Orleans, Louisiana 70112
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New Orleans, Louisiana 70121
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, New Jersey 07103
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Newport News, Virginia 23602
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Philadelphia, Pennsylvania 19104
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Richmond, Virginia 23249
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Saint Louis, Missouri 63110
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington, District of Columbia 20016
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