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

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ClinicalTrials.gov Identifier: NCT01154985

Recruitment Status : Completed

First Posted : July 1, 2010

Results First Posted : November 20, 2014

Last Update Posted : November 20, 2014

Sponsor:

Information provided by (Responsible Party):

Mochida Pharmaceutical Company, Ltd.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Steatohepatitis	Drug: Placebo capsule Drug: EPA-E 300 mg capsule	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	243 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Study Start Date :	June 2010
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Non-alcoholic fatty liver disease

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Arms and Interventions

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
Experimental: EPA-E 2700 mg/day 3x EPA-E 300 mg capsules TID	Drug: EPA-E 300 mg capsule 3x 300 mg capsules TID for 365 days

Outcome Measures

Primary Outcome Measures :

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
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
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154985

Locations

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

Sponsors and Collaborators

Mochida Pharmaceutical Company, Ltd.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier:	NCT01154985
Other Study ID Numbers:	MCH-02-001
First Posted:	July 1, 2010 Key Record Dates
Results First Posted:	November 20, 2014
Last Update Posted:	November 20, 2014
Last Verified:	October 2014

Keywords provided by Mochida Pharmaceutical Company, Ltd.:


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

Additional relevant MeSH terms:

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

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