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Proteinase Inhibitor

Alpha-proteinase Inhibitor for Eosinophilic Esophagitis (ZEEPS Trial)

Phase 2
Recruiting
Led By Marc Rothenberg
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

ZEEPS Trial Summary

This trial will study a drug to help people with Eosinophilic Esophagitis, a type of throat inflammation.

Who is the study for?
Adults aged 18-70 with Eosinophilic Esophagitis (EoE) who've had moderate to severe abdominal/chest pain or swallowing difficulties at least twice a week, and whose symptoms weren't controlled by standard treatments. Participants must be willing to maintain their current diet and medical management for EoE throughout the study.Check my eligibility
What is being tested?
The trial is testing Zemaira (alpha-1 trypsin inhibitor) in patients with Eosinophilic Esophagitis. It's an open-label study, meaning both researchers and participants know what treatment is being given, focusing on how effective this drug is for treating EoE.See study design
What are the potential side effects?
Potential side effects of Zemaira may include allergic reactions or hypersensitivity following infusion, which could manifest as rash, itching, difficulty breathing, or swelling of the face/lips/tongue/throat.

ZEEPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Change in esophageal alpha1 anti-trypsin (A1AT) concentration
Secondary outcome measures
Change in serine protease activity

Side effects data

From 2019 Phase 4 trial • 10 Patients • NCT03126370
20%
Renal events deemed possibly, probably or related
100%
80%
60%
40%
20%
0%
Study treatment Arm
TDF With a Boosted PI
TAF With a Boosted PI
TAF With a Boosted PI and LDV/SOF

ZEEPS Trial Design

1Treatment groups
Experimental Treatment
Group I: Active DrugExperimental Treatment1 Intervention
Zemaira alpha-proteinase inhibitor

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,576 Total Patients Enrolled
16 Trials studying Eosinophilic Esophagitis
7,792 Patients Enrolled for Eosinophilic Esophagitis
CSL BehringIndustry Sponsor
194 Previous Clinical Trials
1,211,051 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,835 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
2,333 Patients Enrolled for Eosinophilic Esophagitis

Media Library

Alpha-proteinase inhibitor (Proteinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05485155 — Phase 2
Eosinophilic Esophagitis Research Study Groups: Active Drug
Eosinophilic Esophagitis Clinical Trial 2023: Alpha-proteinase inhibitor Highlights & Side Effects. Trial Name: NCT05485155 — Phase 2
Alpha-proteinase inhibitor (Proteinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05485155 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this particular research endeavor welcome elderly participants?

"The target population for this study consist of adults aged 18 and above, but below 70 years old."

Answered by AI

Has Active Drug been certified by the FDA?

"The safety of Active Drug was assessed as a 2 since this is in the early stages of development and no efficacy data has been collected yet, although some evidence does support its level of security."

Answered by AI

What is the aggregate number of people joining this clinical trial?

"Indeed, the clinicaltrials.gov page for this medical research confirms that it is actively recruiting patients. The initial post was made on June 21st 2023 and more recent information has been supplied as of June 20th 23. This project requires 15 volunteers to be gathered from a single medical centre."

Answered by AI

Are there vacancies for volunteers in this research endeavor?

"According to the clinicaltrials.gov portal, this medical trial is presently looking for participants and was initially posted on June 21st 2023 with its most recent edit occurring a day prior."

Answered by AI

Is participation in this trial open to the public?

"This clinical trial is currently recruiting 15 individuals diagnosed with eosinophilic esophagitis aged 18 up to 70 years. Participants must have an understanding of the research process and be willing to adhere to all study visits, abide by a stable diet for 8 weeks before enrollment, demonstrate moderate-severe abdominal/chest pain or dysphagia at least 2 episodes per week in the last two weeks prior to screening along with histologically active EoE peak count ≥15eos/hpf without other causes for oesinphilia, and consistently maintain existing medications (including PPI's) dosage levels over the same time period."

Answered by AI
~10 spots leftby Dec 2024