Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2012-12-05
2020-12-31
Brief Summary
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Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Obese patients
No interventions assigned to this group
Non-obese patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Receiving filgrastim at 5mcg/kg ± 10%
* Admitted as an inpatient with an expected stay of at least 24 hours
* Weight is \> 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
* Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
Exclusion Criteria
* Patients who have received pegfilgrastim within 14 days prior to enrollment
* Hypersensitivity reaction to filgrastim or any related product
* Patients who have taken lithium within 7 days of enrollment
* Serum Creatinine \> 1.5 mg/dL
* Patients who are pregnant or breastfeeding
* Patients who are unable to understand and/or render informed consent
18 Years
ALL
No
Sponsors
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Aaron Cumpston, PharmD, BCOP
OTHER
Responsible Party
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Aaron Cumpston, PharmD, BCOP
Clinical Specialist - BMT
Principal Investigators
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Aaron Cumpston, PharmD, BCOP
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Locations
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West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Countries
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References
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Stewart AW, Shillingburg A, Petros W, Wen S, Piktel D, Moses R, Gibson LF, Craig M, Cumpston A. A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Pharmacotherapy. 2022 Jan;42(1):53-57. doi: 10.1002/phar.2646. Epub 2021 Nov 22.
Other Identifiers
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WVU 021112
Identifier Type: -
Identifier Source: org_study_id