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REVERSE Clinical Trial

Senior man talking with his adult sons in garden.

The REVERSE Clnical Study will evaluate the effects of obeticholic acid in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH)

What is NASH?

Nonalcoholic steatohepatitis (NASH) is an advanced form of fatty liver disease. It is caused by excess fat in the liver that leads to inflammation and tissue injury.

What are risk factors for NASH?

People with type 2 diabetes, obesity, high cholesterol, insulin resistance, and high blood pressure may have NASH.

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Learn More

For more information about this research study, please contact:
Cynthia Gifford-Hollingsworth, DrNP
cag26@drexel.edu
267.507.6811

Principal Investigator:
Andres Riera, MD*

Description of Clinical Trial

The REVERSE study will evaluate the effects of obeticholic acid (OCA) treatment on improvement in liver fibrosis in patients with nonalcoholic steatohepatitis (NASH), a form of nonalcoholic fatty liver disease.

The REVERSE study is a phase 3, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of obeticholic acid in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH).

Is this Research Study for You?

Subjects should be at least 18 years of age with a diagnosis of NASH and have some evidence of cirrhosis.

How the Study Works

This study has 2 phases. The first phase lasts about 12 months, and is double blind, meaning neither you nor the investigator site will know if you are taking Obeticholic Acid (OCA). You will be randomized (like flipping a coin) to either the 10 mg dose, the 25 mg dose or a placebo (no active medicine).

Phase 2 is for participants who complete phase 1. It is an Open-Label extension for an additional 12 months, where all participants receive the medication OCA at either 10 mg or 25 mg.

Eligible participants receive study-related medical evaluations and the investigational drug at no charge.

Reimbursement for travel and meal expenses may be provided.

Related Practice

Center for Liver, Biliary and Pancreatic Diseases
230 N. Broad Street, 15th Floor
Philadelphia, PA 19102

Location of the Research Study

216 N Broad Street, 15th Floor
Philadelphia, PA 19102


* Physician's practice/location is independent of Drexel Medicine and Drexel University.

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

The images being used are for illustrative purposes only; any person depicted is a model.

 
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