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

NCT ID: NCT02138253

Last Updated: 2019-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-03-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Fibrosis Hepatic Fibrosis Liver Cirrhosis Hepatic Cirrhosis

Keywords

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liver transplant hepatitis C liver fibrosis hepatic fibrosis liver cirrhosis hepatic cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IDN-6556

IDN-6556 25 mg BID

Group Type EXPERIMENTAL

IDN-6556

Intervention Type DRUG

Placebo

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo control

Interventions

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IDN-6556

Intervention Type DRUG

Placebo

Placebo control

Intervention Type DRUG

Other Intervention Names

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emricasan PF-03491390

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conatus Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Hagerty, MD

Role: STUDY_CHAIR

Conatus Pharmaceuticals Inc.

Locations

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Southern California Research Center

Coronado, California, United States

Site Status

Scripps Clinic

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

UCLA Pfleger Liver Institute

Los Angeles, California, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Johns Hopkins Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Medicine

Chicago, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Tulane Health Science Center

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic

New Orleans, Louisiana, United States

Site Status

John Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Henery Ford Health System

Detroit, Michigan, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of Cincinnati Physicians Company

Cincinnati, Ohio, United States

Site Status

University of Pennsylvania Milton Hershey Hospital

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Baylor All Saints Medical Center

Fort Worth, Texas, United States

Site Status

Liver Associates of Texas, PA

Houston, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

VAMC/Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Bon Secours Mary Immaculate Hospital

Newport News, Virginia, United States

Site Status

Bon Secours St. Mary's Hospital of Richmond

Richmond, Virginia, United States

Site Status

McGuire DVAMC

Richmond, Virginia, United States

Site Status

University of Washington Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IDN-6556-07

Identifier Type: -

Identifier Source: org_study_id