An Open-Label Study of Zemaira (Alpha 1-Trypsin Inhibitor) in Subjects With Eosinophilic Esophagitis
Children's Hospital Medical Center, Cincinnati
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.
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 4 weeks (for a total of 4 infusions). During the treatment period, participants will be monitored for adverse events/reactions and will complete patient reported outcome metri…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant and/or legally authorized representative must be able to understand and provide informed consent prior to study procedures being performed. 2. Willing and able to comply with study visits and activities 3. Age ≥ 18 to ≤ 70 years at study enrollment 4. Histologically active eosinophilic esophagitis (EoE) at time of screening or within 12 weeks prior to enrollment, with a peak count of ≥ 15 eosinophils (eos)/high powered field (hpf) in any region of the esophagus, with no other known cause for esophageal eosinophilia; involvement of eosinophilic inflammation i…
Interventions
- DrugAlpha-proteinase inhibitor
Intravenous infusion at 120 mg/kg body weight dose/week for 4 weeks for a total of 4 infusions.
Locations (2)
- The National Institutes of HealthBethesda, Maryland
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio