Study of IDN-6556 in Patients With Severe AH and Contradictions to Steroid Therapy

This study is currently recruiting participants.
Verified February 2014 by Conatus Pharmaceuticals Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01912404
First received: July 29, 2013
Last updated: February 12, 2014
Last verified: February 2014
  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
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: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in liver function scores [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Worsening of pre-existing organ failure or development of new organ failure [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: July 2017 (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

Detailed Description:

The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver functioning.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 21 years of age or older
  • 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 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
  • 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 (must have eGFR (estimated glomerular filtration rate) >15 mL/min, and not be on dialysis at time of entry into study)

Exclusion Criteria:

  • 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
  • Sepsis as evidenced by positive blood or urine culture, pneumonia as confirmed by x-ray
  • History of renal transplant and/or severe renal impairment defined as eGFR of ≤15 mL/min, or on dialysis at time of entry into study
  • Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
  • Hepatocellular carcinoma (HCC) at entry into the study
  • Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
  • Patients requiring the use of vasopressors or inotropic support
  • Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912404

Contacts
Contact: Gary Burgess, MD +44 7879602104 gburgess@conatuspharma.com

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
Study Director: Gary Burgess, MD Conatus Pharmaceuticals
  More Information

No publications provided

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
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014