Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Alpha-proteinase inhibitor

    Drug

    Intravenous infusion at 120 mg/kg body weight dose/week for 4 weeks for a total of 4 infusions.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Active DrugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in esophageal alpha1 anti-trypsin (A1AT) concentration

Absolute change from baseline A1AT esophageal concentration in participants receiving Zemaira to 24 hours after the last infusion at 4 weeks

Time frame
4 weeks
2

Adverse events

The number of Adverse Events (AE), including Serious Adverse Events (SAE), related to the study drug.

Time frame
20 weeks

Secondary outcomes

1

Change in serine protease activity

Absolute change from baseline serine protease activity in participants receiving Zemaira to the end of treatment visit at 4 weeks as determined by protease activity testing.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

CSL Behring

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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