Zemaira Eosinophilic Esophagitis Pilot Study

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05485155
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Alpha-proteinase inhibitor — DRUG
    Intravenous infusion at 120 mg/kg body weight dose/week for 4 weeks for a total of 4 infusions.

Study Details

This is a prospective, open-label drug study that will examine the effects of Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis.

Key Dates

Start date
May 15, 2025
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active Drug
    Zemaira alpha-proteinase inhibitor

Primary Outcome Measure

Change in esophageal alpha1 anti-trypsin (A1AT) concentration [ Time Frame: 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The National Institutes of HealthBethesdaMaryland20892
Perla Adames-Castillo, RN
[email protected]
Gregory Constantine, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Regina Yearout
[email protected]
513-517-2108
Marc E Rothenberg, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By research site
The National Institutes of Health· Bethesda, MDCincinnati Children's Hospital Medical Center· Cincinnati, OH

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