Clinical Trials Logo
  1. Home
  2. Steatohepatitis
  3. NCT01154985

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 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).

Clinical Trial 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. ;

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

Clinical Trial Details
NCT number NCT01154985
Study type Interventional
Source Mochida Pharmaceutical Company, Ltd.
Contact
Status Completed
Phase Phase 2
Start date June 2010
Completion date October 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Active, not recruiting NCT01246388 - Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy N/A
Terminated NCT05864391 - A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH. Phase 1
Completed NCT01556113 - Genetic Effect on Omega 3 Fatty Acids for the Treatment of Fatty Liver Disease N/A
Completed NCT00886301 - Fatty Liver and Ectopic Fat in Overweight and Obese Patients N/A
Completed NCT02009592 - Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients N/A
Completed NCT01645852 - A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection N/A
Completed NCT00512512 - Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass N/A
Completed NCT03915002 - Integrated Approaches for Identifying Molecular Targets in Liver Disease
Active, not recruiting NCT00326482 - Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
Completed NCT00575757 - Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV N/A
Recruiting NCT05640947 - Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass N/A
Completed NCT01147523 - Effect of Spironolactone and Vitamin E in Patients With Nonalcoholic Fatty Liver Disease Phase 2
Active, not recruiting NCT05946330 - Nutritional Intervention IN Nash NON-ALCOHOLIC (NAFLD). N/A
Active, not recruiting NCT02378259 - Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity N/A
Terminated NCT01523639 - A Randomized, Placebo-controlled, Double-blind Phase II Study Evaluating if Glucophage Can Avoid Liver Injury Due to Chemotherapy Associated Steatosis Phase 2
Recruiting NCT00914446 - Identification of Protective and Worsening Steatohepatitis (NASH) Factors N/A
Active, not recruiting NCT04063826 - PET-MR Study of Fatty Liver N/A