Zemaira Eosinophilic Esophagitis Pilot Study
ConditionEosinophilic Esophagitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.
Eligibility criteria
Qualifiers
Participant and/or legally authorized representative must be able to understand and provide informed consent prior to study procedures being performed.
Willing and able to comply with study visits and activities
Age ≥ 18 to ≤ 70 years at study enrollment
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 in other gastrointestinal segments will be allowed but not required or sufficient.
Disqualifiers
Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
Current active H. pylori infection. A history of H. pylori infection needs to have medical documentation of one of the three acceptable eradication tests: antigen, breath or histology. Participants with current active H. pylori infections can be re-screened for study participation in the future if they are treated and have medical documentation of one of the three acceptable eradication tests: antigen, breath or histology.
Another disorder that causes esophageal eosinophilia (e.g., hypereosinophilic syndrome*, Churg Strauss vasculitis, eosinophilic granuloma or a parasitic infection).
Systemic gastrointestinal disorders such as Crohn's disease, inflammatory bowel disease, or Celiac disease not including chronic gastritis, chronic duodenitis, mucosal eosinophilia or other EGID's.
Trial design
Treatments tested in this trial
- Alpha-proteinase inhibitor
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
CSL Behring
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov