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

NCT01154985 | Completed Phase 2 Results DMC

• 1 other identifier: MCH-02-001
• Study Type: interventional
• Target: 243
• Locations: 2 countries
• Sites: 34

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).

Conditions

Steatohepatitis

Keywords

omega-3 fatty acids; alanine transaminase; triglycerides; lipids; EPA; ethyl-EPA; ethyl icosapentate; Non Alcoholic steatohepatitis; Non Alcoholic fatty liver disease; fatty acids

Outcome Measures

Primary Outcomes (3)

• Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies

  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

  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

  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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

3x placebo capsules TID

Drug: Placebo capsule

EPA-E 1800 mg/day

EXPERIMENTAL

2x EPA-E 300 mg capsules + 1placebo capsule TID

Drug: EPA-E 300 mg capsule

EPA-E 2700 mg/day

EXPERIMENTAL

3x EPA-E 300 mg capsules TID

Drug: EPA-E 300 mg capsule

Interventions

Placebo capsule DRUG

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

Placebo

EPA-E 300 mg capsule DRUG

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

EPA-E 1800 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of definite NASH
• Patients with diabetes taking stable doses of anti-diabetic agents are eligible
• No significant concomitant medical illness

You may not qualify if:

• 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

Sponsors & Collaborators

• Mochida Pharmaceutical Company, Ltd.: lead

Study Sites (34)

Mochida Investigative Site

Dothan, Alabama, 36305, United States

Location

Mochida Investigative Site

Tucson, Arizona, 85712, United States

Location

Mochida Investigative Site

Anaheim, California, 92801, United States

Location

Mochida Investigative Site

Coronado, California, 92118, United States

Location

Mochida Investigative Site

La Jolla, California, 92037, United States

Location

Mochida Investigative Site

Los Angeles, California, 90048, United States

Location

Mochida Investigative Site

San Diego, California, 92123, United States

Location

Mochida Investigative Site

San Diego, California, 92161, United States

Location

Mochida Investigative Site

Littleton, Colorado, 80120, United States

Location

Mochida Investigative Site

Hialeah, Florida, 33016, United States

Location

Mochida Investigative Site

Chicago, Illinois, 60612, United States

Location

Mochida Investigative Site

Lexington, Kentucky, 40536, United States

Location

Mochida Investigative Site

New Orleans, Louisiana, 70112, United States

Location

Mochida Investigative Site

Chevy Chase, Maryland, 20815, United States

Location

Mochida Investigative Site

Detroit, Michigan, 48202, United States

Location

Mochida Investigative Site

Plymouth, Minnesota, 55446, United States

Location

Mochida Investigative Site

Jackson, Mississippi, 39202, United States

Location

Mochida Investigative Site

Tupelo, Mississippi, 38801, United States

Location

Mochida Investigative Site

Plainview, New York, 11803, United States

Location

Mochida Investigative Site

Asheville, North Carolina, 28801, United States

Location

Mochida Investigative Site

Durham, North Carolina, 27713, United States

Location

Mochida Investigative Site

Cincinnati, Ohio, 45219, United States

Location

Mochida Investigative Site

Cincinnati, Ohio, 45242, United States

Location

Mochida Investigative Site

Cleveland, Ohio, 44195, United States

Location

Mochida Investigative Site

Providence, Rhode Island, 02903, United States

Location

Mochida Investigative Site (2 sites)

Germantown, Tennessee, 38138, United States

Location

Mochida Investigative Site

Nashville, Tennessee, 37211, United States

Location

Mochida Investigative Site

Houston, Texas, 77005, United States

Location

Mochida Investigative Site (2 sites)

Houston, Texas, 77030, United States

Location

Mochida Investigative Site

San Antonio, Texas, 78234, United States

Location

Mochida Investigative Site

Newport News, Virginia, 23602, United States

Location

Mochida Investigative Site

Richmond, Virginia, 23298, United States

Location

Mochida Investigative Site

Seattle, Washington, 98101, United States

Location

Mochida Investigative Site

San Juan, Puerto Rico, 00927, Puerto Rico

Location

Related Publications (1)

• Sanyal AJ, Abdelmalek MF, Suzuki A, Cummings OW, Chojkier M; EPE-A Study Group. No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. Gastroenterology. 2014 Aug;147(2):377-84.e1. doi: 10.1053/j.gastro.2014.04.046. Epub 2014 May 9.

  PMID: 24818764 DERIVED

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Hironori Sato, Director
• Organization: Mochida Pharmaceutical Company Ltd.

hnsato@mochida.co.jp

+81-3-3225-6331

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 20, 2014
• Results First Posted: November 20, 2014

Record last verified: 2014-10

Locations

PR (1); US (33)