Last updated on February 2016

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)


Brief description of study

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

Detailed Study Description

To study the investigational drug, obeticholic acid (also known as OCA), and its effect on NASH and to find out how safe and effective OCA may be in delaying specific medical conditions or health related issues that can occur in patients with NASH and evidence of liver fibrosis.

Patients will need to complete 1 or 2 screening visits to see if they are eligible to participate in the study. If eligible, patients will be asked to come back to the clinic 8 times and then every 3 months for the first 18 months they are in the study and then 2 times per year (every 6 months) for each additional year they are in the study. Participation in the study is expected to last for approximately up to 6 years but could be shorter.

Clinical Study Identifier: TX142647

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Szecho Lin

Research Site
Additional Locations, NY USA
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