Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)
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- STATUS
- Recruiting
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- sponsor
- Intercept Pharma
Summary
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)
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.
Estimated Enrollment: 2000
Study Start Date: September 2015
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021
Details
| Condition | Liver Disease, Gastrointestinal Diseases and Disorders |
|---|---|
| Clinical Study Identifier | TX142647 |
| Sponsor | Intercept Pharma |
| Last Modified on | 23 November 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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