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NCT00719719 · ClinicalTrials.gov registry record
Cause of Unexplained Anaphylaxis
A clinical trial of Idiopathic Anaphylaxis and Drug Anaphylaxis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- 115
- Enrollment target
- 1
- Study location
NCT00719719: Active study of Idiopathic Anaphylaxis and Drug Anaphylaxis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00719719 is a study of Idiopathic Anaphylaxis and Drug Anaphylaxis that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 115 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719719, a study of Idiopathic Anaphylaxis and Drug Anaphylaxis, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis. Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact with an allergy-causing substance, usually a particular food, drug or stinging insect. The allergen triggers mast cells to release several substances, including histamine. Histamine is responsible for many of the symptoms that may occur, such as flushing, hives, swelling of the palms and soles or tongue and vocal cords, nasal congestion, itching and tearing of the eyes, shortness of breath and wheezing, stomach pain, vomiting, low blood pressure, loss of consciousness, shock, and, rarely, death. Severe episodes of anaphylaxis are treated with epinephrine (adrenaline), followed by oral antihistamines and steroids. In more than half of cases of anaphylaxis, a clear cause is not identified. These cases are called idiopathic anaphylaxis. There is no cure or long-term preventive therapy for patients with recurrent episodes of idiopathic anaphylaxis. People between 13 and 70 years of age who have idiopathic anaphylaxis, or have anaphylaxis that is caused by specific allergens such as food, venom, or drugs and medications may be eligible for this study. Participants are evaluated at the NIH Clinical Center with the following tests and procedures: * Medical history, physical examination and blood tests. * Bone marrow biopsy. For this test, the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia. Then, a needle is inserted into the hipbone and a small amount of bone marrow is drawn into a syringe. The needle also cuts a small core of bone marrow, which is removed for analysis. * Other tests that may be needed for evaluation of the patient s condition.
Primary Outcome
The primary objective of this study is to determine if patients with anaphylaxis (IA or SA) have clinical \& laboratory features that correlate with genetic or molecular abnormalities in their mast cell population including the presence of clonal mast cell disease.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2008-11-05 |
What the registry record for NCT00719719 still lists
NCT00719719 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.
The record links to 4 conditions, with Idiopathic Anaphylaxis appearing as the primary indexed condition, and to 0 interventions.
NCT00719719 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00719719 about?
NCT00719719 is a clinical study titled "Cause of Unexplained Anaphylaxis". This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis. Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact with an allergy-causing substance, usually a particular food, drug or stinging insect. The allergen triggers mast cells ...
What is the current status of trial NCT00719719?
This trial is currently active not recruiting. The enrollment target is 115 participants. The study started on 2008-11-05.
What conditions does trial NCT00719719 study?
This clinical trial studies the following conditions: Idiopathic Anaphylaxis, Drug Anaphylaxis, Venom Anaphylaxis, Food Anaphylaxis.
Who is sponsoring clinical trial NCT00719719?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00719719 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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