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

NCT01912404 | Terminated Phase 2 Results DMC

• 2 other identifiers: IDN-6556-045U01AA021788
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Alcoholic Hepatitis

Keywords

alcoholic hepatitis

Outcome Measures

Primary Outcomes (1)

• Survival

  28 days

Study Arms (2)

IDN-6556

EXPERIMENTAL

IDN-6556 capsules, 25 mg BID

Drug: IDN-6556

Placebo

PLACEBO COMPARATOR

Placebo capsules BID

Drug: Placebo

Interventions

IDN-6556 DRUG

25 mg BID for 28 days

Also known as: emricasan, PF-03491390

IDN-6556

Placebo DRUG

Placebo controlled

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male or female patients 21 years of age or older
• Patients with alcoholic hepatitis defined as:
• 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
• Consumed alcohol within 6 weeks of entry into the study
• Biochemical parameters of severe disease as evidenced by MELD score \>20 but \<35, or MELD score 35-40 if the SOFA score is \<10
• 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
• Patients with established contraindications to steroid use including but not limited to the following:
• GI bleed
• 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)
• Acute pancreatitis (increased lipase \> 3x ULN or radiologic evidence)
• Positivity for hepatitis B (HBsAg+) or C virus (HCV+), and
• Renal failure

You may not qualify if:

• Other or concomitant cause of liver disease as a result of:
• Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer \>1:160)
• Metabolic liver disease (abnormal ceruloplasmin levels)
• Vascular liver disease
• Drug induced liver disease Note: Concurrent viral hepatitis is not excluded.
• Co-infection with human immunodeficiency virus (HIV)
• Sepsis as evidenced by positive blood or urine culture, or pneumonia as confirmed by x-ray
• History of renal transplant and/or on dialysis at time of entry into study
• Inflammatory bowel disease
• 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)
• Active tuberculosis on chest x-ray at study entry
• History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QT or QTc interval of \>480 milliseconds (msec)
• 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

Sponsors & Collaborators

• Conatus Pharmaceuticals Inc.: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (3)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Limitations and Caveats

Since the study was stopped early, no conclusions regarding efficacy can be made.

Results Point of Contact

• Title: Jean L. Chan, MD
• Organization: Conatus Pharmaceuticals Inc.

jchan@conatuspharma.com

(858) 376-2632

Study Officials

• David Hagerty, MD

  Conatus Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: July 29, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 4, 2016
• Results First Posted: November 4, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)