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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.

Tracking Information
First Submitted Date  ICMJE February 28, 2014
First Posted Date  ICMJE March 4, 2014
Results First Submitted Date  ICMJE March 30, 2016
Results First Posted Date  ICMJE July 21, 2016
Last Update Posted Date August 30, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
Changes in alanine aminotransferase from Baseline [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT02077374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2014)
  • Changes in aspartate aminotransferase from Baseline [ Time Frame: 28 days ]
  • Changes in biomarkers from Baseline [ Time Frame: 28 days ]
    Levels of cCK18, flCK18, and caspase 3/7 will be evaluated
  • Change in homeostatic model assessment-insulin resistance from Baseline [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
Official Title  ICMJE A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: IDN-6556
    25 mg BID for 28 days
    Other Names:
    • emricasan
    • PF-03491390
  • Other: Placebo
    Placebo BID for 28 Days
Study Arms  ICMJE
  • Experimental: IDN-6556
    IDN-6556 capsules, 25 mg BID
    Intervention: Drug: IDN-6556
  • Placebo Comparator: Placebo
    Placebo BID
    Intervention: Other: Placebo
Publications * Shiffman M, Freilich B, Vuppalanchi R, Watt K, Chan JL, Spada A, Hagerty DT, Schiff E. Randomised clinical trial: emricasan versus placebo significantly decreases ALT and caspase 3/7 activation in subjects with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019 Jan;49(1):64-73. doi: 10.1111/apt.15030. Epub 2018 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2014)
40
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02077374
Other Study ID Numbers  ICMJE IDN-6556-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Conatus Pharmaceuticals Inc.
Study Sponsor  ICMJE Conatus Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean L. Chan, MD Conatus Pharmaceuticals
PRS Account Conatus Pharmaceuticals Inc.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP