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NCT00001842 · ClinicalTrials.gov registry record · Phase 1
G-CSF for Granulocyte Donation
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00001842 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 16 participants.
The verdict
NCT00001842, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before. People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called dexamethasone and a growth factor called G-CSF the day before donation. These drugs stimulate white cell production, allowing many more cells to be collected than would otherwise be possible. A single dose of G-CSF given to healthy people increases their white cells counts by four to five times the next day. It would be preferable, however, to give G-CSF the same day of donation, if possible. Therefore, this study will measure white cell counts in healthy people at various intervals after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare the following: granulocyte counts at seven different intervals after injection of the drug or drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of giving G-CSF alone or with dexamethasone. Each participant will undergo four procedures, each four weeks apart as follows: donate a small blood sample; receive an injection of G-CSF under the skin or into a vein; and take either two dexamethasone tablets or two placebo tablets. Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given. Participants will answer questions about how they feel before the drugs are given and at the various intervals after taking the drugs.
Interventions
- DRUG Dexamethasone
- DRUG Granulocyte colony-stimulating factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 1999-07 |
| Est. Completion | 2002-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001842
The ClinicalTrials.gov registry entry for NCT00001842 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00001842 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001842 about?
NCT00001842 is a clinical study titled "G-CSF for Granulocyte Donation". This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before. People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a...
What is the current status of trial NCT00001842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 1999-07. Estimated completion is 2002-06.
What interventions are being tested in trial NCT00001842?
The interventions under investigation include: Dexamethasone (DRUG), Granulocyte colony-stimulating factor (DRUG).
Who is sponsoring clinical trial NCT00001842?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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