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Zemaira Eosinophilic Esophagitis Pilot Study — ZEEPS  

Eosinophilic Esophagitis Clinical Trial

Official title:
An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects With Eosinophilic Esophagitis

Clinical Trial Summary

This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.

Clinical Trial Description

This is a phase II, open-label trial of Zemaira in participants diagnosed with eosinophilic esophagitis. Potential participants will be screened during a 12-week screening period. Participants will be enrolled based on the presence of active disease and their ability to meet the study inclusion and exclusion criteria. Qualifying participants will receive weekly intravenous infusions of 120 mg/kg body weight dose/week for 12 weeks (for a total of 12 infusions). During the treatment period, participants will be monitored for adverse events/reactions and will complete patient reported outcome metrics to track their symptoms and general wellbeing. Final assessments will be performed 24 hours after the last dose of the study drug. All participants will be followed for an additional 12 weeks after the last dose of study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05485155
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact Kara Kliewer
Phone 513-636-4821
Email kara.kliewer@cchmc.org
Status Recruiting
Phase Phase 2
Start date March 1, 2024
Completion date March 1, 2025
View Details
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