Status:
COMPLETED
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Mochida Pharmaceutical Company, Ltd.
Conditions:
Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
This is a phase II, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH. Subjects are required t...
Eligibility Criteria
Inclusion
- Diagnosis of definite NASH
- Patients with diabetes taking stable doses of anti-diabetic agents are eligible
- No significant concomitant medical illness
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01154985
Start Date
June 1 2010
End Date
October 1 2012
Last Update
November 20 2014
Active Locations (34)
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1
Mochida Investigative Site
Dothan, Alabama, United States, 36305
2
Mochida Investigative Site
Tucson, Arizona, United States, 85712
3
Mochida Investigative Site
Anaheim, California, United States, 92801
4
Mochida Investigative Site
Coronado, California, United States, 92118