Obeticholic Acid for Prevention in Barrett's Esophagus

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04939051
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Barrett Esophagus
  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Esophageal Biopsy — PROCEDURE
    Undergo esophageal biopsy, brushings and gastric aspirate
  • Esophagogastroduodenoscopy — PROCEDURE
    Undergo EGD
  • Liver Ultrasonographic Elastography — PROCEDURE
    Undergo liver ultrasound with elastography
  • Obeticholic Acid — BIOLOGICAL
    Given PO
  • Placebo Administration — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary study

Study Details

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.

Key Dates

Start date
Jan 3, 2024
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (OCA)
    Patients receive OCA PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound with elastography during screening, EGD with biopsies, brushings and gastric aspirate at screening and end of treatment visit and blood sample collection throughout the study.
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound with elastography during screening, EGD with biopsies, brushings and gastric aspirate at screening and end of treatment visit and blood sample collection throughout the study.

Primary Outcome Measure

Mean change in leucine-rich repeat-containing G-protein coupled receptor 5+ cell count [ Time Frame: Baseline up to 6 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160
Ajay Bansal
[email protected]
816-861-4700
Ajay Bansal (PRINCIPAL_INVESTIGATOR)
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Scott M. Schuetze
[email protected]
734-647-8925
Scott M. Schuetze (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Dayna S. Early
[email protected]
314-454-5960
Dayna S. Early (PRINCIPAL_INVESTIGATOR)
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Nicholas J. Shaheen
[email protected]
919-966-7047
Nicholas J. Shaheen (PRINCIPAL_INVESTIGATOR)
Case Western Reserve UniversityClevelandOhio44106
Amitabh Chak
[email protected]
216-844-7344
Amitabh Chak (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Prashanthi Thota
[email protected]
216-444-0780
Prashanthi Thota (PRINCIPAL_INVESTIGATOR)
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106
Joseph E. Willis
[email protected]
216-286-0151
Joseph E. Willis (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Amitabh Chak
[email protected]
216-286-0151
Amitabh Chak (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Cancer Center· Kansas City, KSUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIWashington University School of Medicine· St Louis, MOUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NCCase Western Reserve University· Cleveland, OHCleveland Clinic Foundation· Cleveland, OH

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