Testing Obeticholic Acid for Familial Adenomatous Polyposis

Summary

This phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a beneficial effect on the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is a rare gene defect that increases the risk of developing cancer of the intestines and colon. OCA is a drug similar to a bile acid the body makes. It is fluid made and released by the liver. OCA binds to a receptor in the intestine that is believed to have a positive effect on preventing cancer development. OCA has been effective in treating primary biliary cholangitis (PBC), a liver disease, and is approved by the Food and Drug Administration (FDA) for use at a lower dose (10 mg). There have been studies showing that OCA decreases inflammation and fibrosis. However, it is not yet known whether OCA works on reducing the number of polyps in patients with FAP.

Timeline

Start

2023-01-19

Primary completion

2026-03-17

Completion

2026-04-17

Outcome

Outcome not reported

Stopped (Enrollment): “Protocol has been completed prematurely due to poor accrual and study feasibility.”

Drugs

Indications