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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
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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


Arms and Interventions
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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
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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


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
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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


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Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT01154985     History of Changes
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:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
 Digestive System Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors