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

Mochida Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Steatohepatitis

Treatments: Drug: EPA-E 300 mg capsule; Drug: Placebo capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154985

MCH-02-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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243 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

3x placebo capsules TID

Treatment:

Drug: Placebo capsule

EPA-E 1800 mg/day

Experimental group

Description:

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

Treatment:

Drug: EPA-E 300 mg capsule

Drug: EPA-E 300 mg capsule

EPA-E 2700 mg/day

Experimental group

Description:

3x EPA-E 300 mg capsules TID

Treatment:

Drug: EPA-E 300 mg capsule

Drug: EPA-E 300 mg capsule