CLINICAL TRIALS PROFILE FOR OCALIVA
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All Clinical Trials for OCALIVA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04939051 ↗ | Obeticholic Acid for Prevention in Barrett's Esophagus | Not yet recruiting | National Cancer Institute (NCI) | Phase 2 | 2021-12-08 | This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid, may help increase bile flow from the liver while suppressing bile acid production, therefore reducing the exposure of the liver to toxic levels of bile acids which is potentially linked to cancer development. |
| NCT05112822 ↗ | Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) | Not yet recruiting | M.D. Anderson Cancer Center | Phase 1 | 2022-03-31 | This is a trial that intends to evaluate the effect of treatment with the drug obeticholic acid in the treatment of the Familial Adenomatous Polyposis condition. |
| NCT05223036 ↗ | Testing Obeticholic Acid for Familial Adenomatous Polyposis | Not yet recruiting | National Cancer Institute (NCI) | Phase 2 | 2022-07-11 | This phase IIa trial investigates if giving obeticholic acid (OCA) has an 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 bile acids, a fluid made and released by the liver. It 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). 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. |
| NCT05740631 ↗ | The Effect of Obeticholic Acid in Healthy Volunteers | Recruiting | Intercept Pharmaceuticals | N/A | 2022-08-22 | This study investigates whether obeticholic acid affects gut microbiota, gastric motility, accommodation, and gastrointestinal peptide in healthy subjects. This study is a single-blind, placebo-controlled, randomized study. Twelve healthy volunteers will take one tablet containing obeticholic acid (10 mg) or a placebo once per day for 21 days for the first intervention. After 28 days washout period, they will take a tablet different from the one taken in the first intervention. Before the first intervention, they will receive MMC, IGP and endoscopy exam. At the end of the first and second interventions, they will receive the same exams. During MMC&IGP, we will take blood samples to measure plasma hormones (motilin, octa-ghrelin, GLP-1, GLP-2, GIP, and insulin) and take duodenal fluid. When the endoscopy, we will take samples from the duodenal for microbiota, permeability measurement, RNA, protein, and pathology. Before and during the interventions, stool samples will be collected. |
| NCT05740631 ↗ | The Effect of Obeticholic Acid in Healthy Volunteers | Recruiting | Universitaire Ziekenhuizen KU Leuven | N/A | 2022-08-22 | This study investigates whether obeticholic acid affects gut microbiota, gastric motility, accommodation, and gastrointestinal peptide in healthy subjects. This study is a single-blind, placebo-controlled, randomized study. Twelve healthy volunteers will take one tablet containing obeticholic acid (10 mg) or a placebo once per day for 21 days for the first intervention. After 28 days washout period, they will take a tablet different from the one taken in the first intervention. Before the first intervention, they will receive MMC, IGP and endoscopy exam. At the end of the first and second interventions, they will receive the same exams. During MMC&IGP, we will take blood samples to measure plasma hormones (motilin, octa-ghrelin, GLP-1, GLP-2, GIP, and insulin) and take duodenal fluid. When the endoscopy, we will take samples from the duodenal for microbiota, permeability measurement, RNA, protein, and pathology. Before and during the interventions, stool samples will be collected. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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