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

November 13, 2014 updated by: Mochida Pharmaceutical Company, Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Mochida Investigative Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Mochida Investigative Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Mochida Investigative Site
    • California
      • Anaheim, California, United States, 92801
        • Mochida Investigative Site
      • Coronado, California, United States, 92118
        • Mochida Investigative Site
      • LaJolla, California, United States, 92037
        • Mochida Investigative Site
      • Los Angeles, California, United States, 90048
        • Mochida Investigative Site
      • San Diego, California, United States, 92123
        • Mochida Investigative Site
      • San Diego, California, United States, 92161
        • Mochida Investigative Site
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Mochida Investigative Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Mochida Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Mochida Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Mochida Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Mochida Investigative Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Mochida Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Mochida Investigative Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Mochida Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Mochida Investigative Site
      • Tupelo, Mississippi, United States, 38801
        • Mochida Investigative Site
    • New York
      • Plainview, New York, United States, 11803
        • Mochida Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mochida Investigative Site
      • Durham, North Carolina, United States, 27713
        • Mochida Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Mochida Investigative Site
      • Cincinnati, Ohio, United States, 45242
        • Mochida Investigative Site
      • Cleveland, Ohio, United States, 44195
        • Mochida Investigative Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Mochida Investigative Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Mochida Investigative Site (2 sites)
      • Nashville, Tennessee, United States, 37211
        • Mochida Investigative Site
    • Texas
      • Houston, Texas, United States, 77005
        • Mochida Investigative Site
      • Houston, Texas, United States, 77030
        • Mochida Investigative Site (2 sites)
      • San Antonio, Texas, United States, 78234
        • Mochida Investigative Site
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Mochida Investigative Site
      • Richmond, Virginia, United States, 23298
        • Mochida Investigative Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Mochida Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
3x placebo capsules TID
Drug: Placebo capsule
3x Placebo capsules three times a day (TID) for 365 days
EXPERIMENTAL: EPA-E 1800 mg/day
2x EPA-E 300 mg capsules + 1placebo capsule TID
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
EXPERIMENTAL: EPA-E 2700 mg/day
3x EPA-E 300 mg capsules TID
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
Time Frame: 12 months

Patient is considered a responder if histological examination shows:

Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis

A priori threshold for statistical significance is p<0.05, 1-sided
12 months
Alanine Transaminase (ALT) Levels
Time Frame: 3 month endpoint

Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;

  1. EPA-E 2700 mg and Placebo groups
  2. EPA-E 1800 mg and Placebo groups
3 month endpoint
Alanine Transaminase (ALT) Levels
Time Frame: 6 months

Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;

  1. EPA-E 2700 mg and Placebo groups
  2. EPA-E 1800 mg and Placebo groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mochida Pharmaceutical Company, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCH-02-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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