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

NCT ID: NCT01154985

Last Updated: 2014-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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

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Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

3x placebo capsules TID

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DRUG

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

EPA-E 1800 mg/day

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

Group Type EXPERIMENTAL

EPA-E 300 mg capsule

Intervention Type DRUG

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

EPA-E 2700 mg/day

3x EPA-E 300 mg capsules TID

Group Type EXPERIMENTAL

EPA-E 300 mg capsule

Intervention Type DRUG

3x 300 mg capsules TID for 365 days

Interventions

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Placebo capsule

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

Intervention Type DRUG

EPA-E 300 mg capsule

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

Intervention Type DRUG

EPA-E 300 mg capsule

3x 300 mg capsules TID for 365 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mochida Pharmaceutical Company, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mochida Investigative Site

Dothan, Alabama, United States

Site Status

Mochida Investigative Site

Tucson, Arizona, United States

Site Status

Mochida Investigative Site

Anaheim, California, United States

Site Status

Mochida Investigative Site

Coronado, California, United States

Site Status

Mochida Investigative Site

La Jolla, California, United States

Site Status

Mochida Investigative Site

Los Angeles, California, United States

Site Status

Mochida Investigative Site

San Diego, California, United States

Site Status

Mochida Investigative Site

San Diego, California, United States

Site Status

Mochida Investigative Site

Littleton, Colorado, United States

Site Status

Mochida Investigative Site

Hialeah, Florida, United States

Site Status

Mochida Investigative Site

Chicago, Illinois, United States

Site Status

Mochida Investigative Site

Lexington, Kentucky, United States

Site Status

Mochida Investigative Site

New Orleans, Louisiana, United States

Site Status

Mochida Investigative Site

Chevy Chase, Maryland, United States

Site Status

Mochida Investigative Site

Detroit, Michigan, United States

Site Status

Mochida Investigative Site

Plymouth, Minnesota, United States

Site Status

Mochida Investigative Site

Jackson, Mississippi, United States

Site Status

Mochida Investigative Site

Tupelo, Mississippi, United States

Site Status

Mochida Investigative Site

Plainview, New York, United States

Site Status

Mochida Investigative Site

Asheville, North Carolina, United States

Site Status

Mochida Investigative Site

Durham, North Carolina, United States

Site Status

Mochida Investigative Site

Cincinnati, Ohio, United States

Site Status

Mochida Investigative Site

Cincinnati, Ohio, United States

Site Status

Mochida Investigative Site

Cleveland, Ohio, United States

Site Status

Mochida Investigative Site

Providence, Rhode Island, United States

Site Status

Mochida Investigative Site (2 sites)

Germantown, Tennessee, United States

Site Status

Mochida Investigative Site

Nashville, Tennessee, United States

Site Status

Mochida Investigative Site

Houston, Texas, United States

Site Status

Mochida Investigative Site (2 sites)

Houston, Texas, United States

Site Status

Mochida Investigative Site

San Antonio, Texas, United States

Site Status

Mochida Investigative Site

Newport News, Virginia, United States

Site Status

Mochida Investigative Site

Richmond, Virginia, United States

Site Status

Mochida Investigative Site

Seattle, Washington, United States

Site Status

Mochida Investigative Site

San Juan, Puerto Rico, Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 24818764 (View on PubMed)

Other Identifiers

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MCH-02-001

Identifier Type: -

Identifier Source: org_study_id