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

Alcoholic Hepatitis Clinical Trial

— AH  

Official title:

A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01912404
• Other study ID #: IDN-6556-04
• Secondary ID: 5U01AA021788
• Status: Terminated
• Phase: Phase 2
• First received: July 29, 2013
• Last updated: September 25, 2015
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Conatus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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, or MELD score 35-40 if the SOFA score is <10

• 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:

• 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 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)

• Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis, Alcoholic

Intervention

Drug:
• IDN-6556
25 mg BID for 28 days
• Placebo
Placebo controlled

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Conatus Pharmaceuticals Inc.	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		28 days	Yes
Secondary	Survival		6 months	No
Secondary	Change in liver function scores		28 days	Yes
Secondary	Worsening of pre-existing organ failure or development of new organ failure		28 days	Yes