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Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy (AH)

This study has been terminated.
(Due to concern for high systemic drug levels that could exceed levels in toxicology studies.)
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01912404
First received: July 29, 2013
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.

Condition Intervention Phase
Alcoholic Hepatitis
Drug: IDN-6556
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy

Resource links provided by NLM:


Further study details as provided by Conatus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 capsules BID
Drug: Placebo
Placebo controlled

Detailed Description:
The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide written informed consent (either from patient or patient's legally acceptable representative), and understand and willing to comply with the requirements of the study
  2. Male or female patients 21 years of age or older
  3. Patients with alcoholic hepatitis defined as:

    1. History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for most days in a minimum period of 6 months
    2. Consumed alcohol within 6 weeks of entry into the study
    3. Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10
  4. Willingness to utilize 2 reliable forms of contraception (for both males and females of childbearing potential) from screening to 1 month after the completion of study treatment
  5. Patients with established contraindications to steroid use including but not limited to the following:

    1. GI bleed
    2. Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
    3. Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
    4. Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
    5. Renal failure

Exclusion Criteria:

  1. Other or concomitant cause of liver disease as a result of:

    1. Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
    2. Metabolic liver disease (abnormal ceruloplasmin levels)
    3. Vascular liver disease
    4. Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
  2. Co-infection with human immunodeficiency virus (HIV)
  3. Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
  4. History of renal transplant and/or on dialysis at time of entry into study
  5. Inflammatory bowel disease
  6. Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
  7. Hepatocellular carcinoma (HCC) at entry into the study
  8. Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
  9. Active tuberculosis on chest x-ray at study entry
  10. History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec)
  11. Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
  12. Patients requiring the use of vasopressors or inotropic support
  13. Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
  14. Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study Note: Investigational drug includes any drug that is used off-label.
  15. If female, known pregnancy, or has a positive urine or serum pregnancy test, or lactating/breastfeeding
  16. If male, if partner is known to be pregnant at time of entry into study or becomes pregnant while patient is on study drug or up to 1 month after completion of study drug
  17. Appropriate candidate for corticosteroid therapy
  18. Treatment for alcohol hepatitis within 1 month of study entry with use of corticosteroids for >1 week or corticosteroid use at the time of entry into the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912404

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Director: David Hagerty, MD Conatus Pharmaceuticals
  More Information

Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01912404     History of Changes
Other Study ID Numbers: IDN-6556-04  5U01AA021788 
Study First Received: July 29, 2013
Results First Received: July 29, 2016
Last Updated: September 16, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Study was terminated early with insufficient subjects for meaningful analysis.

Keywords provided by Conatus Pharmaceuticals Inc.:
alcoholic hepatitis

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on December 02, 2016