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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

Inclusion Criteria:

• Diagnosis of definite NASH

• Patients with diabetes taking stable doses of anti-diabetic agents are eligible

• No significant concomitant medical illness

Exclusion Criteria:

• Diagnosis of cirrhosis.

• Serum ALT > 300 U/L

• Use of drugs associated with steatohepatitis

• Use of the following anit-NASH agents:

1. Vitamin E > 60 IU per day

2. Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day

3. 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