Phase 2 N=243 Randomized Triple-blind Treatment

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

Steatohepatitis

Bottom Line

View on ClinicalTrials.gov: NCT01154985 ↗

Enrolled (actual)

243

Serious AEs

7.0%

Results posted

Nov 2014

Primary outcome: Primary: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies — 18; 18; 20 participants — p=0.57

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo capsule (Drug); EPA-E 300 mg capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mochida Pharmaceutical Company, Ltd.
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies	18; 18; 20	0.57
PRIMARY Alanine Transaminase (ALT) Levels	-19.1; -9.5; -3.0	0.1592
PRIMARY Alanine Transaminase (ALT) Levels	-19.1; -9.5; -3.0	0.1592

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).

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

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Data sourced from ClinicalTrials.gov (NCT01154985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.