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NCT Number: NCT01154985

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

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Key information

Conditions

Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mochida Investigative Site, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Placebo capsule

Drug

3x Placebo capsules three times a day (TID) for 365 days

EPA-E 300 mg capsule

Drug

2x 300 mg capsules + placebo capsule TID for 365 days

Primary outcomes

  1. 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

  2. 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;

    • EPA-E 2700 mg and Placebo groups
    • EPA-E 1800 mg and Placebo groups

  3. 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;

    • EPA-E 2700 mg and Placebo groups
    • EPA-E 1800 mg and Placebo groups

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 1, 2010
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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