Overview

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