Actively Recruiting
Obeticholic Acid for Prevention in Barrett's Esophagus
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
30
Participants Needed
8
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Obeticholic Acid for Prevention in Barrett's Esophagus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known diagnosis of Barrett's esophagus confirmed by biopsy with no, indefinite, or low-grade dysplasia and at least 2 cm involvement seen on endoscopy
- Adequate Barrett's mucosa with at least one biopsy sample having 50% or more intestinal metaplasia
- On proton pump inhibitor therapy for at least 28 days
- Age 18 years or older
- ECOG performance status of 1 or less (Karnofsky score 70% or higher)
- Hemoglobin of 10 g/dL or higher or hematocrit of 30% or higher
- Leukocyte count of 3,500/microliter or higher
- Platelet count of 100,000/microliter or higher
- Creatinine clearance of 30 mL/min/1.73m2 or higher
- AST and ALT levels less than or equal to 1.5 times the institutional upper limit of normal
- Total bilirubin less than or equal to institutional upper limit of normal
- Alkaline phosphatase less than or equal to 1.5 times the institutional upper limit of normal
- Gamma-glutamyl transferase less than or equal to 1.5 times the institutional upper limit of normal
- Agreement to use effective contraception before, during, and for 6 months after the study if of childbearing potential
- Ability to understand study procedures and provide informed consent
- Willingness to undergo HIV and hepatitis B and C testing if not tested in the past 6 months
- Willingness and ability to follow study restrictions
- Willingness to moderate alcohol intake (no more than 1 drink per day for women, 2 for men)
- No evidence of active or recurrent invasive cancer in the past 6 months and at least 6 months since prior cancer treatment
You will not qualify if you...
- History of prior ablative therapy in Barrett's esophagus segment
- Prior use of obeticholic acid
- History or presence of high-grade dysplasia or cancer on pre-intervention endoscopy
- Severe skin diseases causing intense itching
- Active or suspected chronic liver diseases including cirrhosis, NASH with fibrosis or cirrhosis, primary sclerosing cholangitis, or biliary atresia
- Acute cholecystitis
- History of pancreatitis or pancreatic abnormalities
- Hepatic steatosis with velocity over 1.7 m/sec by liver ultrasound elastography
- Uncontrolled hyperlipidemia despite treatment
- Severe or unstable medical, psychiatric, or metabolic conditions that could affect safety or compliance
- Known allergies or intolerance to the study drug or similar compounds
- Active untreated hepatitis B or C infection
- Use of prohibited medications unless willing to stop them before starting study treatment
- Pregnant or breastfeeding women, or unwillingness to use reliable contraception if of childbearing potential
- Receiving other investigational agents currently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
2
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
6
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
7
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
8
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here