A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
POLT-HCV-SVR
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
1 other identifier
interventional
64
1 country
35
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.
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 May 2014
Typical duration for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2018
CompletedResults Posted
Study results publicly available
December 11, 2019
CompletedDecember 11, 2019
November 1, 2019
3.8 years
May 12, 2014
May 2, 2019
November 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score
At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations.
24 months
Secondary Outcomes (11)
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)
24 months
Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score
12 months
Alanine Aminotransferase (ALT) - Change From Baseline
Baseline and 24 months
Aspartate Aminotransferase (AST) Change From Baseline
Baseline and 24 months
Caspase 3/7 Change From Baseline
Baseline and 24 months
- +6 more secondary outcomes
Study Arms (2)
IDN-6556
EXPERIMENTALIDN-6556 25 mg BID
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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Southern California Research Center
Coronado, California, 92118, United States
Scripps Clinic
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
UCLA Pfleger Liver Institute
Los Angeles, California, 90095, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Johns Hopkins Sibley Memorial Hospital
Washington D.C., District of Columbia, 21287, 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
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tulane Health Science Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henery Ford Health System
Detroit, Michigan, 48202, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45267, United States
University of Pennsylvania Milton Hershey Hospital
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104, United States
Liver Associates of Texas, PA
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
VAMC/Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
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
Richmond, Virginia, 23226, United States
McGuire DVAMC
Richmond, Virginia, 23249, United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The broad range of fibrosis stages included in the study and the high placebo response rates especially in the F2 and F6 fibrosis stages impacted the primary endpoint of improvement in fibrosis score from baseline.
Results Point of Contact
- Title
- Steven Mento, Ph.D., CEO
- Organization
- Conatus Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
David Hagerty, MD
Conatus Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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
May 12, 2014
First Posted
May 14, 2014
Study Start
May 1, 2014
Primary Completion
February 15, 2018
Study Completion
March 9, 2018
Last Updated
December 11, 2019
Results First Posted
December 11, 2019
Record last verified: 2019-11