<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719432</url>
  </required_header>
  <id_info>
    <org_study_id>WVU 021112</org_study_id>
    <nct_id>NCT01719432</nct_id>
  </id_info>
  <brief_title>Effect of Body Mass on Filgrastim Pharmacokinetics</brief_title>
  <official_title>Effect of Body Mass on Filgrastim Pharmacokinetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aaron Cumpston, PharmD, BCOP</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies have shown that different percentages of body fat can alter the way drugs are&#xD;
      distributed in the body. This study will use blood samples taken at different time points for&#xD;
      patients taking Neupogen to determine if higher body weights affect drug exposure. The&#xD;
      information gathered from this study will help understand if patients with higher body&#xD;
      weights need a different dosing plan.&#xD;
&#xD;
      Patients in this study will have blood draws once before they take Neupogen and 6 times after&#xD;
      they take the Neuopen (for a total of 24 hours). These patients will be in the hospital&#xD;
      already and will not need to make additional trips back to have blood drawn. A total of about&#xD;
      5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched,&#xD;
      non-obese patients will be enrolled into this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2012</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Systemic clearance of filgrastim in obese and non-obese patients</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alpha and beta half-life of filgrastim in obese and non-obese patients</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) of filgrastim in obese and non-obese patients</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Hematological Malignancy</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Obese patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-obese patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Obese and non-obese patients receiving filgrastim&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Receiving filgrastim at 5mcg/kg ± 10%&#xD;
&#xD;
          -  Admitted as an inpatient with an expected stay of at least 24 hours&#xD;
&#xD;
          -  Weight is &gt; 190% of their ideal body weight (IBW) for &quot;obese&quot; patients or within 80 -&#xD;
             124% of IBW for matched control patients.&#xD;
&#xD;
          -  Patient or their legally authorized representative understands and voluntarily signs&#xD;
             the written informed consent prior to any study-specific procedures. A copy of the&#xD;
             signed informed consent form will be retained by the treating institution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received filgrastim within 24 hours prior to enrollment&#xD;
&#xD;
          -  Patients who have received pegfilgrastim within 14 days prior to enrollment&#xD;
&#xD;
          -  Hypersensitivity reaction to filgrastim or any related product&#xD;
&#xD;
          -  Patients who have taken lithium within 7 days of enrollment&#xD;
&#xD;
          -  Serum Creatinine &gt; 1.5 mg/dL&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients who are unable to understand and/or render informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Cumpston, PharmD, BCOP</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Virginia University Mary Babb Randolph Cancer Center</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Aaron Cumpston, PharmD, BCOP</investigator_full_name>
    <investigator_title>Clinical Specialist - BMT</investigator_title>
  </responsible_party>
  <keyword>Filgrastim</keyword>
  <keyword>Obese</keyword>
  <keyword>Non-obese</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719432
org study id: WVU 021112
nct id: NCT01719432
lead sponsor: 
has dmc: Yes
Studies have shown that different percentages of body fat can alter the way drugs are
      distributed in the body. This study will use blood samples taken at different time points for
      patients taking Neupogen to determine if higher body weights affect drug exposure. The
      information gathered from this study will help understand if patients with higher body
      weights need a different dosing plan.

      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.
observational model: Case-Control
time perspective: Prospective
measure: Systemic clearance of filgrastim in obese and non-obese patients
time frame: 24 hours
measure: Alpha and beta half-life of filgrastim in obese and non-obese patients
time frame: 24 hours
measure: Maximum concentration (Cmax) of filgrastim in obese and non-obese patients
time frame: 24 hours
measure: Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients
time frame: 24 hours
measure: Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients
time frame: 24 hours
arm group label: Obese patients
arm group label: Non-obese patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aaron Cumpston, PharmD, BCOP
role: Principal Investigator
affiliation: West Virginia University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: West Virginia University
investigator full name: Aaron Cumpston, PharmD, BCOP
investigator title: Clinical Specialist - BMT
mesh term: Hematologic Neoplasms
mesh term: Neutropenia