NCT05609253

Itraconazole to Prevent Recurrent Barrett's Esophagus

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Barrett Oesophagitis With Dysplasia

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-09-14
• Primary completion: 2024-02-23
• Completion: 2026-06-30
• First posted: 2022-11-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study