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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: December 6, 2012
Last verified: December 2012
History of Changes
  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
Drug: EPA-E
 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:

U.S. FDA Resources

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 ]
  • Alanine transaminase (ALT) levels [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall histological score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Individual histological feature scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 Drug: Placebo
Placebo capsule three times a day (TID) for 365 days
Experimental: EPA-E 1800 mg/day Drug: EPA-E
600 mg capsule TID for 365 days
Experimental: EPA-E 2700 mg/day Drug: EPA-E
900 mg capsule 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
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

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
Last Updated: December 6, 2012
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
Liver Diseases
Digestive System Diseases
Eicosapentaenoic acid ethyl ester
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013