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NCT05223036 · ClinicalTrials.gov registry record · Phase 2
Testing Obeticholic Acid for Familial Adenomatous Polyposis
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT05223036: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT05223036 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05223036, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Placebo Administration
- PROCEDURE Gastrointestinal Endoscopy
- BIOLOGICAL Obeticholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-01-19 |
| Est. Completion | 2026-04-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05223036
The ClinicalTrials.gov registry entry for NCT05223036 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05223036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05223036 about?
NCT05223036 is a clinical study titled "Testing Obeticholic Acid for Familial Adenomatous Polyposis". 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 ...
What is the current status of trial NCT05223036?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-01-19. Estimated completion is 2026-04-17.
What interventions are being tested in trial NCT05223036?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Placebo Administration (DRUG), Gastrointestinal Endoscopy (PROCEDURE), Obeticholic Acid (BIOLOGICAL).
Who is sponsoring clinical trial NCT05223036?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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