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NCT00024934 · ClinicalTrials.gov registry record · Phase 1
B-Lymphocyte Stimulator (BLyS) To Treat Selective IgA Deficiency
A Phase 1 study of IgA Deficiency, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00024934 is a Phase 1 study of IgA Deficiency that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00024934, a Phase 1 study of IgA Deficiency, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety of BlyS, an experimental drug being developed to treat immune deficiency. As of July 17, 2001, 7 persons with common variable immune deficiency (CVID) have received BlyS, with no problems reported. This study will test the safety of the drug in people with IgA deficiency. Patients 18 years of age and older with IgA deficiency who have recurrent or chronic sinus or lung infections or chronic diarrhea or malabsorption may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests, electrocardiogram (EKG), chest X-ray and a breathing test (spirometry). Participants will be divided into five groups of three persons each to receive different doses (0.1, 1, 5, 15 or 45 micrograms/kilogram of body weight) of BlyS. The first group will receive a single dose at the lowest dose level (0.l mg). Each succeeding group will receive a single higher dose following a 2-week observation period of the preceding group. The drug will be injected under the skin, with vital signs (temperature, pulse, blood pressure and breathing rate) monitored for one hour after dosing. Blood samples will be collected several times on the day of dosing (before the dose and at 1.5, 3, 5, 8 and 12 hours after the dose) and again at 1,2, 4, 8 and 12 weeks after the dose to measure BlyS levels and evaluate safety. Participants receiving one of the three higher doses will have additional blood samples collected 36, 48 and 60 hours after the dose. Blood will also be collected from all participants 6 and 12 months after dosing to look for any unexpected long-term effects. A total of 289 ml (1.2 cups) of blood will be collected. Blood will be checked for changes in blood count, kidney and liver function, antibody levels and autoimmune problems. Saliva will be collected four times by placing a cotton ball in the mouth-once before the dose and three times after the dose-to measure antibody levels. Urine samples will also be coll
Conditions Studied
Interventions
- DRUG B-Lymphocyte Stimulator (BLyS)
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2001-10 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00024934
The ClinicalTrials.gov registry entry for NCT00024934 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with IgA Deficiency appearing as the primary indexed condition, and to 1 intervention - of which B-Lymphocyte Stimulator (BLyS) is the first listed.
NCT00024934 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00024934 about?
NCT00024934 is a clinical study titled "B-Lymphocyte Stimulator (BLyS) To Treat Selective IgA Deficiency". This study will examine the safety of BlyS, an experimental drug being developed to treat immune deficiency. As of July 17, 2001, 7 persons with common variable immune deficiency (CVID) have received BlyS, with no problems reported. This study will test the safety of the drug in people with IgA defi...
What is the current status of trial NCT00024934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2001-10. Estimated completion is 2004-08.
What conditions does trial NCT00024934 study?
This clinical trial studies the following conditions: IgA Deficiency.
What interventions are being tested in trial NCT00024934?
The interventions under investigation include: B-Lymphocyte Stimulator (BLyS) (DRUG).
Who is sponsoring clinical trial NCT00024934?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00024934 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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