Eosinophilic Esophagitis Clinical Trial
Official title:
An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects With Eosinophilic Esophagitis
This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.
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. ;
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