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Effect of Body Mass on Filgrastim Pharmacokinetics


N/A
18 Years
N/A
Open (Enrolling)
Both
Hematological Malignancy, Pharmacokinetics of Filgrastim

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Trial Information

Effect of Body Mass on Filgrastim Pharmacokinetics


Inclusion Criteria:



- Age greater than or equal to 18 years

- 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 filgrastim within 24 hours prior to enrollment

- 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Systemic clearance of filgrastim in obese and non-obese patients

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

Aaron Cumpston, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

West Virginia University

Authority:

United States: Institutional Review Board

Study ID:

WVU 021112

NCT ID:

NCT01719432

Start Date:

October 2012

Completion Date:

February 2014

Related Keywords:

  • Hematological Malignancy
  • Pharmacokinetics of Filgrastim
  • Filgrastim
  • Obese
  • Non-obese
  • Pharmacokinetics
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

West Virginia University Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506