Clinical trial NCT01154985: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies
timeFrame: 12 months
measure: Alanine Transaminase (ALT) Levels
timeFrame: 3 month endpoint
measure: Alanine Transaminase (ALT) Levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Mochida Investigative Site
state: Alabama
city: Tucson
country: United States
facility: Mochida Investigative Site
state: Arizona
city: Anaheim
country: United States
facility: Mochida Investigative Site
state: California
city: Coronado
country: United States
facility: Mochida Investigative Site
state: California
city: LaJolla
country: United States
facility: Mochida Investigative Site
state: California
city: Los Angeles
country: United States
facility: Mochida Investigative Site
state: California
city: San Diego
country: United States
facility: Mochida Investigative Site
state: California
city: San Diego
country: United States
facility: Mochida Investigative Site
state: California
city: Littleton
country: United States
facility: Mochida Investigative Site
state: Colorado
city: Hialeah
country: United States
facility: Mochida Investigative Site
state: Florida
city: Chicago
country: United States
facility: Mochida Investigative Site
state: Illinois
city: Lexington
country: United States
facility: Mochida Investigative Site
state: Kentucky
city: New Orleans
country: United States
facility: Mochida Investigative Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Mochida Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Mochida Investigative Site
state: Michigan
city: Plymouth
country: United States
facility: Mochida Investigative Site
state: Minnesota
city: Jackson
country: United States
facility: Mochida Investigative Site
state: Mississippi
city: Tupelo
country: United States
facility: Mochida Investigative Site
state: Mississippi
city: Plainview
country: United States
facility: Mochida Investigative Site
state: New York
city: Asheville
country: United States
facility: Mochida Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Mochida Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Mochida Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Mochida Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Mochida Investigative Site
state: Ohio
city: Providence
country: United States
facility: Mochida Investigative Site
state: Rhode Island
city: Germantown
country: United States
facility: Mochida Investigative Site (2 sites)
state: Tennessee
city: Nashville
country: United States
facility: Mochida Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Mochida Investigative Site
state: Texas
city: Houston
country: United States
facility: Mochida Investigative Site (2 sites)
state: Texas
city: San Antonio
country: United States
facility: Mochida Investigative Site
state: Texas
city: Newport News
country: United States
facility: Mochida Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Mochida Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Mochida Investigative Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Mochida Investigative Site
Study officials:
References:
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.