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A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases (NAFLD)

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ClinicalTrials.gov Identifier: NCT02077374
Recruitment Status : Completed
First Posted : March 4, 2014
Results First Posted : July 21, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Drug: IDN-6556 Other: Placebo Phase 2

Detailed Description:
This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Arm Intervention/treatment
Experimental: IDN-6556
IDN-6556 capsules, 25 mg BID
Drug: IDN-6556
25 mg BID for 28 days
Other Names:
  • emricasan
  • PF-03491390

Placebo Comparator: Placebo
Placebo BID
Other: Placebo
Placebo BID for 28 Days




Primary Outcome Measures :
  1. Change in Alanine Aminotransferase (ALT) [ Time Frame: Day 28/ET ]
    Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo

  2. Relative Percent Change in Alanine Aminotransferase (ALT) [ Time Frame: Baseline to Day 28/ET ]
    Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo


Secondary Outcome Measures :
  1. Change in Aspartate Aminotransferase (AST) [ Time Frame: Day 28/ET ]
    Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.

  2. Levels of cCK18/M30 [ Time Frame: Day 28/ET ]
    Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo

  3. Levels of Caspase 3/7 RLU [ Time Frame: Day 28/ET ]
    Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo

  4. Levels of flCK18/M65 [ Time Frame: Day 28/ET ]
    Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo



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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 understand and comply with the requirements of the study
  • Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
  • Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
  • alpha-fetoprotein (AFP) ≤ 100 ng/mL
  • Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
  • If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study

Exclusion Criteria:

  • Known infection with HIV, HCV, or HBV
  • Decompensated or severe liver disease as evidenced by one or more of the following:

    1. Confirmed cirrhosis or suspicion of cirrhosis
    2. Esophageal varices
    3. Ascites
    4. Suspicion of portal hypertension
    5. Hospitalization for liver disease within 60 days of screening
    6. Bilirubin >2 x ULN, or ALT or AST > 10 x ULN
  • Inflammatory bowel disease
  • Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
  • Hepatocellular carcinoma (HCC) at entry into the study
  • History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
  • Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
  • History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years

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): NCT02077374


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
United States, Virginia
Mary Immaculate Hospital
Newport News, Virginia, United States, 23602
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
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Study Director: Jean L. Chan, MD Conatus Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02077374     History of Changes
Other Study ID Numbers: IDN-6556-06
First Posted: March 4, 2014    Key Record Dates
Results First Posted: July 21, 2016
Last Update Posted: August 30, 2016
Last Verified: July 2016

Keywords provided by Conatus Pharmaceuticals Inc.:
NAFLD
NASH

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases