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NCT01814059 · ClinicalTrials.gov registry record · Phase 1
Sirolimus for Eosinophil-Associated Gastrointestinal Disorders
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01814059 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 4 participants.
The verdict
NCT01814059, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
Background: * Eosinophil-associated gastrointestinal disorders (EGID) are a group of related disorders that affect the esophagus, stomach, and bowel. There are two major types of EGID, eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the body's immune system being activated by food allergens, which then damages the gut wall. People with EGID have large numbers of eosinophils (a type of white blood cell) in their gut. EGID can cause difficulty swallowing, abdominal pain, or nausea. * At present, there are no drugs specifically approved to treat EGID. Most adults who have EGID receive steroid therapy to manage the symptoms. However, long-term steroid use may cause other problems in the body. Researchers want to see if low-dose sirolimus can be used to treat EGID. Sirolimus is a drug used to prevent rejection of transplanted organs. It may be able to keep the body's immune cells from being activated by food allergens and decrease the eosinophils. Objectives: \- To see if low dose sirolimus is safe and decreases blood or gut eosinophils in EGID. Eligibility: * Individuals between 18 to 65 years of age who have EGID. * Participants must also have an elevated blood eosinophil count and positive blood tests for IgE antibodies to foods. Design: * Participants who are on medicine for EGID or related symptoms must be on a stable dose for 1 month before screening and stay on that dose throughout the study. * Participants will be screened with a medical history and physical exam, and review their symptoms. They will provide blood and urine samples. They will also have heart and lung function tests. Some participants may have allergy skin tests. * At the first study visit, participants will have 2 days of inpatient tests. They will repeat the tests from the screening visit. They will also have a full analysis of the esophagus, stomach, and small intestine. On the second day, they will start to take sirolimus as a liquid with orange juice or wa
Interventions
- DRUG sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-03-07 |
| Est. Completion | 2015-05-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01814059
The ClinicalTrials.gov registry entry for NCT01814059 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 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 sirolimus is the first listed.
NCT01814059 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01814059 about?
NCT01814059 is a clinical study titled "Sirolimus for Eosinophil-Associated Gastrointestinal Disorders". Background: * Eosinophil-associated gastrointestinal disorders (EGID) are a group of related disorders that affect the esophagus, stomach, and bowel. There are two major types of EGID, eosinophilic esophagitis and eosinophilic gastroenteritis. They are caused by the body's immune system being activ...
What is the current status of trial NCT01814059?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2013-03-07. Estimated completion is 2015-05-12.
What interventions are being tested in trial NCT01814059?
The interventions under investigation include: sirolimus (DRUG).
Who is sponsoring clinical trial NCT01814059?
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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