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Zemaira Eosinophilic Esophagitis Pilot Study

NCT05485155 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

Alpha-proteinase inhibitor

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

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Marc Rothenberg · Cincinnati Children's Hospital Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-10-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485155 on ClinicalTrials.gov