OncoMatch/Clinical Trials/NCT04939051
Obeticholic Acid for Prevention in Barrett's Esophagus
Is NCT04939051 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Obeticholic Acid for barrett esophagus.
Treatment: Obeticholic Acid — 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 has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Excluded: Stage HIGH-GRADE DISEASE (HGD), CANCER
Grade: no dysplasiaindefinite for dysplasialow-grade dysplasia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: ablative therapy in BE segment (radiofrequency ablation, cryotherapy, argon plasma coagulation)
History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment
Cannot have received: obeticholic acid (obeticholic acid)
Prior use of OCA
Lab requirements
Blood counts
Hemoglobin >= 10g/dL or hematocrit >= 30%; leukocyte count >= 3,500/microliter; platelet count >= 100,000/microliter
Kidney function
Creatinine clearance >= 30 mL/min/1.73m^2
Liver function
AST/ALT <= 1.5 X ULN; total bilirubin <= 1.0 X ULN; alkaline phosphatase <= 1.5 X ULN; GGT <= 1.5 X ULN
Hemoglobin >= 10g/dL or hematocrit >= 30 %; Leukocyte count >= 3,500/microliter; Platelet count >= 100,000/microliter; Creatinine clearance >= 30mL/min/1.73m^2; AST/ALT <= 1.5 X ULN; total bilirubin <= 1.0 X ULN; alkaline phosphatase <=1.5 X ULN; GGT <= 1.5 X ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kansas Cancer Center · Kansas City, Kansas
- University of Michigan Rogel Cancer Center · Ann Arbor, Michigan
- Washington University School of Medicine · St Louis, Missouri
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
- Case Western Reserve University · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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