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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


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
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