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

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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.

Study Description
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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.

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


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Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
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Study Chair: David Hagerty, MD Conatus Pharmaceuticals
More Information
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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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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases