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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier:
NCT01154985
First received: June 29, 2010
Last updated: November 13, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Steatohepatitis
Drug: Placebo capsule
Drug: EPA-E 300 mg capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH

Resource links provided by NLM:


Further study details as provided by Mochida Pharmaceutical Company, Ltd.:

Primary Outcome Measures:
  • Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Enrollment: 243
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154985

  Show 34 Study Locations
Sponsors and Collaborators
Mochida Pharmaceutical Company, Ltd.
  More Information

No publications provided by Mochida Pharmaceutical Company, Ltd.

Additional 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
Study First Received: June 29, 2010
Results First Received: October 15, 2014
Last Updated: November 13, 2014
Health Authority: United States: Food and Drug Administration

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
Digestive System Diseases
Liver Diseases
Eicosapentaenoic acid ethyl ester
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014