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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: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 16 participants
Start Date 1999-07
Est. Completion 2002-06
Phase Phase 1

What the finished NCT00001842 record still lists

NCT00001842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.

NCT00001842 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001842's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001842, the US trial registry maintained by the National Library of Medicine. NCT00001842 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.