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ACTIVE NOT RECRUITING
NCT05609253
PHASE1

Itraconazole to Prevent Recurrent Barrett's Esophagus

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure

Official title: Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2022-09-14

Completion Date

2026-06-30

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Itraconazole in capsule form

Patients with high-risk BE will receive two weeks of itraconazole in the capsule form (N=5).

DRUG

Itraconazole in solution form

Patients with high-risk BE will receive two weeks of itraconazole in the solution form (N=5).

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States