NCT01154985

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

A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Mochida Pharmaceutical Company, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 to have a liver biopsy with proven NASH in the 6 month period prior to screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. Subjects will be stratified at randomization by presence or absence of diabetes. Duration of treatment is 12 months.

Conditions

• Steatohepatitis

Interventions

Type	Name	Description
DRUG	Placebo capsule	3x Placebo capsules three times a day (TID) for 365 days
DRUG	EPA-E 300 mg capsule	2x 300 mg capsules + placebo capsule TID for 365 days
DRUG	EPA-E 300 mg capsule	3x 300 mg capsules TID for 365 days

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-07-01
• Last updated: 2014-11-20
• Results posted: 2014-11-20

Locations

34 sites across 2 countries: United States, Puerto Rico