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

Primary Purpose

Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo capsule
EPA-E 300 mg capsule
EPA-E 300 mg capsule
Sponsored by
Mochida Pharmaceutical Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steatohepatitis focused on measuring omega-3 fatty acids, alanine transaminase, triglycerides, lipids, EPA, ethyl-EPA, ethyl icosapentate, Non Alcoholic steatohepatitis, Non Alcoholic fatty liver disease, fatty acids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site (2 sites)
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site (2 sites)
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site
  • Mochida Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

EPA-E 1800 mg/day

EPA-E 2700 mg/day

Arm Description

3x placebo capsules TID

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

3x EPA-E 300 mg capsules TID

Outcomes

Primary Outcome Measures

Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
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
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; EPA-E 2700 mg and Placebo groups EPA-E 1800 mg and Placebo groups
Alanine Transaminase (ALT) Levels
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; EPA-E 2700 mg and Placebo groups EPA-E 1800 mg and Placebo groups

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
November 13, 2014
Sponsor
Mochida Pharmaceutical Company, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01154985
Brief Title
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
Official Title
A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steatohepatitis
Keywords
omega-3 fatty acids, alanine transaminase, triglycerides, lipids, EPA, ethyl-EPA, ethyl icosapentate, Non Alcoholic steatohepatitis, Non Alcoholic fatty liver disease, fatty acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3x placebo capsules TID
Arm Title
EPA-E 1800 mg/day
Arm Type
Experimental
Arm Description
2x EPA-E 300 mg capsules + 1placebo capsule TID
Arm Title
EPA-E 2700 mg/day
Arm Type
Experimental
Arm Description
3x EPA-E 300 mg capsules TID
Intervention Type
Drug
Intervention Name(s)
Placebo capsule
Intervention Description
3x Placebo capsules three times a day (TID) for 365 days
Intervention Type
Drug
Intervention Name(s)
EPA-E 300 mg capsule
Intervention Description
2x 300 mg capsules + placebo capsule TID for 365 days
Intervention Type
Drug
Intervention Name(s)
EPA-E 300 mg capsule
Intervention Description
3x 300 mg capsules TID for 365 days
Primary Outcome Measure Information:
Title
Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
Description
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
Time Frame
12 months
Title
Alanine Transaminase (ALT) Levels
Description
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; EPA-E 2700 mg and Placebo groups EPA-E 1800 mg and Placebo groups
Time Frame
3 month endpoint
Title
Alanine Transaminase (ALT) Levels
Description
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; EPA-E 2700 mg and Placebo groups EPA-E 1800 mg and Placebo groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Vitamin E > 60 IU per day Omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day 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
Facility Information:
Facility Name
Mochida Investigative Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Mochida Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Mochida Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Mochida Investigative Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Mochida Investigative Site
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Mochida Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mochida Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Mochida Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Mochida Investigative Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Mochida Investigative Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Mochida Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mochida Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Mochida Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Mochida Investigative Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Mochida Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mochida Investigative Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mochida Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Mochida Investigative Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Mochida Investigative Site
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Mochida Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Mochida Investigative Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Mochida Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Mochida Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Mochida Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mochida Investigative Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Mochida Investigative Site (2 sites)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Mochida Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Mochida Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Mochida Investigative Site (2 sites)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mochida Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Mochida Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Mochida Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Mochida Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Mochida Investigative Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24818764
Citation
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.
Results Reference
derived

Learn more about this trial

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

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