Clinical Trial: Zemaira Eosinophilic Esophagitis Pilot Study
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects With Eosinophilic Esophagitis
Brief 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.
Detailed Summary: 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.
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Absolute change from baseline A1AT esophageal concentration in participants receiving Zemaira to 24 hours after the last infusion at 12 weeks
Original Primary Outcome: Absolute change from baseline A1AT esophageal concentration in participants receiving Zemaira to 24 hours after the last infusion at 12 weeks
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: August 01, 2022
Date Started: September 21, 2023
Date Completion: September 21, 2023
Last Updated: September 01, 2023
Last Verified: August 01, 2023