Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

Completed · Phase 2 · Has a placebo group

Conditions studied: Steatohepatitis

In brief

This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

Key facts

Study ID

NCT01154985

Run by

Mochida Pharmaceutical Company, Ltd.

People needed

243

Starts

2010-06-01

Expected to finish

2012-10-01

Last updated by the study team

2014-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of definite NASH
• Patients with diabetes taking stable doses of anti-diabetic agents are eligible
• No significant concomitant medical illness

You may not qualify if…

• Diagnosis of cirrhosis.
• Serum ALT > 300 U/L
• Use of drugs associated with steatohepatitis
• Use of the following anit-NASH agents:
• Vitamin E > 60 IU per day
• Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day
• Thiazolidinediones (e.g. pioglitazone)
• Use of non-stable doses of the following anti-NASH agents: HMGCoA reductase inhibitors (statins), fibrates, probucol, ezetimibe, ursodiol (UDCA), taurine, betaine, N-acetylcysteine, s-adenosylmethionine (SAM-E), milk thistle, anti-TNF therapies, or probiotics.
• Other liver disease

Where it is running

• Mochida Investigative Site — Dothan, Alabama, United States
• Mochida Investigative Site — Tucson, Arizona, United States
• Mochida Investigative Site — Anaheim, California, United States
• Mochida Investigative Site — Coronado, California, United States
• Mochida Investigative Site — La Jolla, California, United States
• Mochida Investigative Site — Los Angeles, California, United States
• Mochida Investigative Site — San Diego, California, United States
• Mochida Investigative Site — San Diego, California, United States
• Mochida Investigative Site — Littleton, Colorado, United States
• Mochida Investigative Site — Hialeah, Florida, United States
• Mochida Investigative Site — Chicago, Illinois, United States
• Mochida Investigative Site — Lexington, Kentucky, United States
• Mochida Investigative Site — New Orleans, Louisiana, United States
• Mochida Investigative Site — Chevy Chase, Maryland, United States
• Mochida Investigative Site — Detroit, Michigan, United States
• Mochida Investigative Site — Plymouth, Minnesota, United States
• Mochida Investigative Site — Jackson, Mississippi, United States
• Mochida Investigative Site — Tupelo, Mississippi, United States
• Mochida Investigative Site — Plainview, New York, United States
• Mochida Investigative Site — Asheville, North Carolina, United States
• Mochida Investigative Site — Durham, North Carolina, United States
• Mochida Investigative Site — Cincinnati, Ohio, United States
• Mochida Investigative Site — Cincinnati, Ohio, United States
• Mochida Investigative Site — Cleveland, Ohio, United States
• Mochida Investigative Site — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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