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Trial record 1 of 1 for:    MCH 02-001
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Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

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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


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




Primary Outcome Measures :
  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;

    1. EPA-E 2700 mg and Placebo groups
    2. 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;

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



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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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors