A phase 2, randomised, double-blind, out-patient trial to determine if YF476 is a safe and effective treatment in patients with Barrett's esophagus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
gastrin receptor antagonist
placebo
Columbia University, Division of Digestive & Liver Diseases
New York, New York, United States
MRC Cancer Unit, University of Cambridge
Cambridge, Cambridgeshire, United Kingdom
Change in Ki67 Biomarker Expression
Esophagogastroduodenoscopy (EGD) was performed to enable taking biopsies for assessment of Ki67 expression, a marker of cellular proliferation. Ki67 expression was assessed by immunohistochemistry and calculating the number of Ki67 positive cells per mm\^2 of Barrett's epithelium.
Time frame: Baseline and Week 12
Expression of Biomarkers Potentially Associated With Esophageal Adenocarcinoma (EAC)
Blood samples were taken for assay of biomarkers associated with esophageal adenocarcinoma. Changes in biomarker expression were derived from RNA-Sequencing and calculated as log-fold change comparing the treatment group to the placebo group. The nature of how results are derived by RNA-sequencing means summary statistics cannot be generated individually for each arm and a value has not been calculated for each individual participant. Therefore, results are reported as the relative change in biomarker expression in the treatment arm compared to the placebo arm.
Time frame: Week 12
Abundance of Biomarkers of Gastric Acid Suppression
Blood samples were taken to assess the effects of YF476 on fasting serum gastrin, a marker of gastric acid suppression
Time frame: Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment)
Abundance of Biomarkers of ECL Cell Hyperplasia
Blood samples were taken to assess the effects of YF476 on fasting plasma CgA, a marker of ECL cell hyperplasia
Time frame: Week 4, Week 6, Week 8, Week 12 and Follow-up (4 weeks after stopping YF476 treatment)
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