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NCT04128371 · ClinicalTrials.gov registry record · Phase 2
Mepolizumab in Episodic Angioedema With Eosinophilia
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04128371 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 5 participants.
The verdict
NCT04128371, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: Gleich syndrome is also called episodic angioedema with eosinophilia (EAE). People with EAE have episodes of swelling. They may also have itching, hives, fever, and weight gain. During episodes, the body has very high numbers of white blood cells, especially a kind called eosinophils. Researchers think a drug called mepolizumab could help. Objective: To see if mepolizumab causes EAE symptoms to be less severe and happen less often. Eligibility: People ages 18 or older with EAE. Design: Participants will be screened under NIH protocol 94-I-0079. Participants will have 8 visits over about 6 months. The timing of some visits will depend on each participant s EAE episodes. Visits will include: * Medical history * Physical exam * Blood and urine tests * Optional bone marrow collection at first or second visit. For this, a needle will be inserted through the participant s hip bone into the marrow. Participants will get mepolizumab 3 times over about 3 months. They will get their first dose when their eosinophils are at their lowest point. They will get the drug by IV. A needle will guide a thin plastic tube into an arm vein. The drug will be given through the tube over about 30 minutes. Participants will keep a daily online log for about 3 months. The log will track their weight, temperature, and EAE symptoms. During the whole study, they will complete 2 online questionnaires about their symptoms. They will fill out 1 daily and 1 monthly. Participants will have blood and urine tests 2-3 times a week. For these, they will go to their local doctor.
Interventions
- BIOLOGICAL mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2022-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128371
The ClinicalTrials.gov registry entry for NCT04128371 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which mepolizumab is the first listed.
NCT04128371 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04128371 about?
NCT04128371 is a clinical study titled "Mepolizumab in Episodic Angioedema With Eosinophilia". Background: Gleich syndrome is also called episodic angioedema with eosinophilia (EAE). People with EAE have episodes of swelling. They may also have itching, hives, fever, and weight gain. During episodes, the body has very high numbers of white blood cells, especially a kind called eosinophils. R...
What is the current status of trial NCT04128371?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-01-14. Estimated completion is 2022-10-31.
What interventions are being tested in trial NCT04128371?
The interventions under investigation include: mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04128371?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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