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

Steatohepatitis Clinical Trial

Official title:

A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154985
• Other study ID #: MCH-02-001
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2010
• Last updated: November 13, 2014
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2014
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Steatohepatitis

Intervention

Drug:
• Placebo capsule
3x Placebo capsules three times a day (TID) for 365 days
• EPA-E 300 mg capsule
2x 300 mg capsules + placebo capsule TID for 365 days
• EPA-E 300 mg capsule
3x 300 mg capsules TID for 365 days

Locations

Country	Name	City	State
Puerto Rico	Mochida Investigative Site	San Juan
United States	Mochida Investigative Site	Anaheim	California
United States	Mochida Investigative Site	Asheville	North Carolina
United States	Mochida Investigative Site	Chevy Chase	Maryland
United States	Mochida Investigative Site	Chicago	Illinois
United States	Mochida Investigative Site	Cincinnati	Ohio
United States	Mochida Investigative Site	Cincinnati	Ohio
United States	Mochida Investigative Site	Cleveland	Ohio
United States	Mochida Investigative Site	Coronado	California
United States	Mochida Investigative Site	Detroit	Michigan
United States	Mochida Investigative Site	Dothan	Alabama
United States	Mochida Investigative Site	Durham	North Carolina
United States	Mochida Investigative Site (2 sites)	Germantown	Tennessee
United States	Mochida Investigative Site	Hialeah	Florida
United States	Mochida Investigative Site	Houston	Texas
United States	Mochida Investigative Site (2 sites)	Houston	Texas
United States	Mochida Investigative Site	Jackson	Mississippi
United States	Mochida Investigative Site	LaJolla	California
United States	Mochida Investigative Site	Lexington	Kentucky
United States	Mochida Investigative Site	Littleton	Colorado
United States	Mochida Investigative Site	Los Angeles	California
United States	Mochida Investigative Site	Nashville	Tennessee
United States	Mochida Investigative Site	New Orleans	Louisiana
United States	Mochida Investigative Site	Newport News	Virginia
United States	Mochida Investigative Site	Plainview	New York
United States	Mochida Investigative Site	Plymouth	Minnesota
United States	Mochida Investigative Site	Providence	Rhode Island
United States	Mochida Investigative Site	Richmond	Virginia
United States	Mochida Investigative Site	San Antonio	Texas
United States	Mochida Investigative Site	San Diego	California
United States	Mochida Investigative Site	San Diego	California
United States	Mochida Investigative Site	Seattle	Washington
United States	Mochida Investigative Site	Tucson	Arizona
United States	Mochida Investigative Site	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Primary	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	3 month endpoint	No
Primary	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	6 months	No