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Farnesoid X receptor agonist
Obeticholic Acid for Barrett's Esophagus
Phase 2
Recruiting
Led By Dean E Brenner
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial studies how to reduce cancer risk in people with Barrett's esophagus using obeticholic acid to reduce bile acid levels.
Who is the study for?
This trial is for adults over 18 with Barrett's Esophagus (BE) who have been on proton pump inhibitors for at least a month. They should not have high-grade dysplasia or cancer, no history of ablative therapy in the BE segment, and must be generally healthy without chronic liver disease or uncontrolled illnesses. Participants need to use contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing obeticholic acid (OCA), which may reduce damage from bile acids in the esophagus by activating FXR to lower bile acid levels and inflammation. It includes questionnaires, biospecimen collection, biopsies, ultrasonography, endoscopy procedures, OCA administration versus placebo.See study design
What are the potential side effects?
Potential side effects of obeticholic acid include itching (pruritus), fatigue, digestive issues like abdominal pain and constipation, headache, dizziness, skin reactions such as rash or eczema. There might also be an increased risk of liver-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am mostly active and can care for myself.
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At least one of my biopsy samples shows significant changes typical of Barrett's esophagus.
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I have been taking medication for acid reflux or stomach ulcers for at least a month.
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I have Barrett's esophagus with no, low, or uncertain dysplasia, confirmed by biopsy and it affects at least 2 cm of my esophagus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change Leucine-rich repeat-containing G-protein coupled receptor 5 (LGR) 5+ cells
Other outcome measures
CDX2/SOX2 and p53 staining
Changes in markers
FGF-19 analysis
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (OCA)Experimental Treatment6 Interventions
Patients receive OCA PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound during screening, EGD with biopsies, brushings and gastric aspirate at end of treatment visit and blood sample collection throughout the study.
Group II: Arm II (placebo)Placebo Group6 Interventions
Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound during screening, EGD with biopsies, brushings and gastric aspirate at end of treatment visit and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980
Biospecimen Collection
2004
Completed Phase 2
~1700
Obeticholic Acid
2015
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,411 Total Patients Enrolled
Dean E BrennerPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly active and can care for myself.I am not pregnant or breastfeeding.I have had recent gallbladder inflammation or a blockage in my bile ducts.At least one of my biopsy samples shows significant changes typical of Barrett's esophagus.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am 18 years old or older.You have had allergic reactions to ursodeoxycholic acid in the past.My heart disease is not under control.I have a skin condition that causes severe itching.I have previously used OCA.I have never had treatments like radiofrequency ablation or cryotherapy on my BE segment.I have had high-grade dysplasia or cancer found in a previous endoscopy.I have a chronic liver condition such as cirrhosis or NASH.My cholesterol levels are not under control.I am currently taking warfarin.I am not taking medications that increase bile salts in my liver.I have been taking medication for acid reflux or stomach ulcers for at least a month.I have Barrett's esophagus with no, low, or uncertain dysplasia, confirmed by biopsy and it affects at least 2 cm of my esophagus.I am not taking medications like cholestyramine, colestipol, or colesevelam.I am not taking medications like clozapine, theophylline, or tizanidine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (placebo)
- Group 2: Arm I (OCA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still an option?
"This clinical trial, which was originally posted on the 27th of July 2023 is still actively searching for participants. Data hosted on clinicaltrials.gov was last updated two days ago (8/2/2023)."
Answered by AI
How extensively is this trial being administered across multiple areas?
"This clinical trial has 6 sites available for participants, including University of Michigan Comprehensive Cancer Center in Ann Arbor, Washington University in St. Louis in Saint Louis, and University of North carolina Chapel Hill; plus 3 other locations."
Answered by AI
What has been the Food and Drug Administration's assessment of OCA as a therapeutic option?
"Our team at Power has assigned a score of 2 to Arm I (OCA) due to the presence of preliminary safety data, yet absence of efficacy evidence from Phase 2 trials."
Answered by AI
Is this research experimental or established?
"Arm I (OCA) has been under clinical evaluation since 2015. The initial exploration was sponsored by Intercept Pharmaceuticals, which conducted a trial involving 2480 participants and subsequently the drug gained Phase 3 approval. Currently, there are 5 active studies associated with this medication in 143 cities across 31 nations."
Answered by AI
What prior studies have utilized the OCA regimen?
"OCA's first clinical trial took place in 2015 at A.O.U. Città della Salute e della Scienza di Torino, with 40 since then being concluded and 5 presently ongoing trials; many of these occurring in Ann Arbor, Michigan."
Answered by AI
What is the upper limit of patients involved in this research endeavor?
"This medical trial requires 30 participants who meet the specified inclusion criteria. Patients may join at either University of Michigan Comprehensive Cancer Center in Ann Arbor, or Washington University in St Louis, Missouri."
Answered by AI
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