Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02322151 · ClinicalTrials.gov registry record
Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 4
- Enrollment target
NCT02322151 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 4 participants.
The verdict
NCT02322151 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
Background: \- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these studies, it is now recommended that a nursing mother should not breastfeed from the time she receives the first dose of the drug until 2 days after the final dose. Researchers want to study the amount of the drug and its effect on the cells present in donor blood and breast milk. They hope to better understand the effects of this drug on breast milk. Objectives: \- To understand the effects of filgrastim on breast milk. Eligibility: \- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding. Design: * Participants will receive rGCSF daily for 5 days. They will have blood taken daily. * Participants will get a freezer bag containing 10 sterile, labeled containers for breast milk collection. * Participants will transfer some of the breast milk they pump into one of the containers. They will write the date and time the milk was collected on the container. They will freeze the samples. Any remaining milk should be disposed of. * Participants will bring the samples to NIH on the day of their stem cell collection procedure. * For days 1 and 2 after stem cell collection, participants will continue to collect and freeze breast milk samples and dispose of any remaining milk. * For days 3 5 after stem cell collection, participants will collect and freeze samples. They can also resume normal breastfeeding. * A research nurse will arrange to collect the samples.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2016-10-14 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02322151
The ClinicalTrials.gov registry entry for NCT02322151 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 4 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 0 interventions.
NCT02322151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02322151 about?
NCT02322151 is a clinical study titled "Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor". Background: \- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these ...
What is the current status of trial NCT02322151?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2014-12-12. Estimated completion is 2016-10-14.
Who is sponsoring clinical trial NCT02322151?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.