The REGENERATE Study (Research Study for Treatment of NASH (Non-Alcoholic Steato-Hepatitis)/Advanced Fatty-Liver Disease)

  • STATUS
    Not Recruiting
  • sponsor
    Intercept Pharmaceuticals
Updated on 23 November 2020

Summary

The REGENERATE Study (Research Study for Treatment of NASH (Non-Alcoholic Steato-Hepatitis)/Advanced Fatty-Liver Disease)

Description

The purpose of this study is to find out how safe and effective OCA may be in delaying or preventing specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis. The investigational drug, OCA, is a modified (man-made) version of a compound in the liver called a bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function.

In this research study, eligible NASH participants will be assigned to receive the investigational drug OCA or placebo. The study treatment will be assigned randomly (like flipping a coin) with two-thirds of the participants assigned to OCA (either 10mg or 25mg) and the other one-third to placebo. Neither the participant nor the doctor will know what study treatment has been assigned. Both OCA and Placebo will be given as a pill(s) to be taken once a day.

Participants will remain on the study and continue to receive the study medication or placebo until the study is completed. It is estimated that patients will participate for a minimum of approximately 6 years. During this time, participants will be evaluated by the study team after the first month of treatment and then once every three months through Month 18. Following the Month 18 visit, participants will be evaluated two times per year (every six-months) for each additional year in the study.

Study participants will be compensated for their time and travel related to the study. NASH is liver inflammation and damage caused by a buildup of fat in the liver. It is an increasingly common chronic liver disease closely associated with diabetes and obesity. NASH is part of a group of conditions called nonalcoholic fatty liver disease (NAFLD) or "fatty liver”. As NASH progresses it results in liver fibrosis (damaged and scarred liver tissue) which may lead to cirrhosis, liver failure and the need for liver transplantation. Currently, there are no therapies approved for the treatment of NASH. To prevent or slow disease progression, physicians commonly recommend lifestyle changes including diet and exercise.

Details
Condition Non-Alcoholic Fatty Liver Disease
Clinical Study IdentifierTX148373
SponsorIntercept Pharmaceuticals
Last Modified on23 November 2020

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