Actively Recruiting
Zemaira Eosinophilic Esophagitis Pilot Study
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-12-17
15
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
C
CSL Behring
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.
CONDITIONS
Official Title
Zemaira Eosinophilic Esophagitis Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Willing and able to comply with study visits and activities
- Age 18 to 70 years at enrollment
- Histologically active eosinophilic esophagitis with at least 15 eosinophils per high powered field
- History of about 8 weeks of standard care treatment that failed to control or was not tolerated
- Stable medical management of eosinophilic esophagitis and related conditions for 8 weeks prior
- Willing to maintain current diet stable for 8 weeks before baseline endoscopy
You will not qualify if you...
- Unable or unwilling to provide informed consent or comply with protocol
- Current active Helicobacter pylori infection
- Other disorders causing esophageal eosinophilia like hypereosinophilic syndrome or parasitic infection
- Systemic gastrointestinal diseases like Crohn's or celiac disease (except certain mild conditions)
- Diagnosed with chronic obstructive pulmonary disease
- Known immunoglobulin A deficiency
- Current COVID-19 infection
- Blood clotting disorders or on anticoagulation medications except aspirin/NSAIDs
- Hypersensitivity to human blood products or Zemaira
- Uncontrolled cardiovascular diseases, hypertension, or diabetes
- Recent or active cancer with specified remission periods
- Recent investigational drug use or participation in other clinical studies
- Steroid-responsive diseases with recent exacerbations
- Current use of systemic steroids above specified doses
- Pregnancy or breastfeeding
- Esophageal strictures or varices posing risk for endoscopy
- Recent history of alcohol or drug abuse
- Immediate family member on investigational team
- Significant lab abnormalities as defined
- Planned major surgery during study
- Known or suspected immunodeficiency
- Planned use of prohibited medications
- Current use of Zemaira for other reasons
- Recent changes in certain medications prior to baseline endoscopy
- Presence of specific esophageal disorders like achalasia or Barrett's esophagus
- Unwillingness to use highly effective contraception if applicable
- Other medical problems posing additional risks or interfering with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The National Institutes of Health
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
R
Regina Yearout
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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