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NCT00017862 · ClinicalTrials.gov registry record · Phase 2
Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
A Phase 2 study of Hypereosinophilic Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00017862: Completed Phase 2 study of Hypereosinophilic Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00017862 is a Phase 2 study of Hypereosinophilic Syndrome that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 132-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00017862, a Phase 2 study of Hypereosinophilic Syndrome, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety and effectiveness of a single dose of anti-interleukin-5 antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in patients with hypereosinophilic syndrome. Patients with this disease have too many eosinophils in the blood and in body tissues, which cause damage to the affected organs-most commonly the heart, nerves and skin. SCH 55700 is an antibody to interleukin 5-a hormone-like substance produced by white blood cells that plays a significant role in eosinophilia. SCH 55700 has lowered eosinophilia blood counts in patients with asthma and reduced the number of these cells in tissues of animals with asthma. Patients with hypereosinophilic syndrome 18 years of age and older who have not responded to standard therapy with steroids, interferon and hydroxyurea or cannot take these drugs may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examination, and blood tests. Depending on the patient's symptoms, other diagnostic tests may be done, including studies of the eyes, lungs, skin, nerves or heart. Skin biopsy and bronchoalveolar lavage may be included in the diagnostic evaluation. For the skin biopsy, a small area about 1/3 inch in diameter is numbed and a small core of skin is surgically removed for study under the microscope. Bronchoalveolar lavage involves inserting a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue sample. This test will be done only if clinically necessary. Those enrolled in the study will be admitted to the NIH Clinical Center for a single dose of SCH 55700, injected into an arm vein. They will be monitored in the hospital for at least 72 hours for changes in eosinophil count and side effects of the injection. After discharge, laboratory tests will be done weekly for the first month, either at the Clinical Center or by the patient's local physician. Follow-up visits will then b
Conditions Studied
Interventions
- DRUG SCH55700
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2001-06 |
| Est. Completion | 2003-06 |
| Phase | Phase 2 |
What the finished NCT00017862 record still lists
NCT00017862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 132-participant average among 7 other Hypereosinophilic Syndrome trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Hypereosinophilic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which SCH55700 is the first listed.
NCT00017862 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00017862 about?
NCT00017862 is a clinical study titled "Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome". This study will examine the safety and effectiveness of a single dose of anti-interleukin-5 antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in patients with hypereosinophilic syndrome. Patients with this disease have too many eosinophils in the blood and in bo...
What is the current status of trial NCT00017862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2001-06. Estimated completion is 2003-06.
What conditions does trial NCT00017862 study?
This clinical trial studies the following conditions: Hypereosinophilic Syndrome.
What interventions are being tested in trial NCT00017862?
The interventions under investigation include: SCH55700 (DRUG).
Who is sponsoring clinical trial NCT00017862?
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 NCT00017862 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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