Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 1:01 PM
Study NCT ID:
NCT01719432
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Body Mass on Filgrastim Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic clearance of filgrastim in obese and non-obese patients', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Alpha and beta half-life of filgrastim in obese and non-obese patients', 'timeFrame': '24 hours'}, {'measure': 'Maximum concentration (Cmax) of filgrastim in obese and non-obese patients', 'timeFrame': '24 hours'}, {'measure': 'Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients', 'timeFrame': '24 hours'}, {'measure': 'Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Filgrastim', 'Obese', 'Non-obese', 'Pharmacokinetics'], 'conditions': ['Hematological Malignancy', 'Neutropenia']}, 'referencesModule': {'references': [{'pmid': '34767652', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese and non-obese patients receiving filgrastim', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Receiving filgrastim at 5mcg/kg ± 10%\n* Admitted as an inpatient with an expected stay of at least 24 hours\n* Weight is \\> 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.\n* 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.\n\nExclusion Criteria:\n\n* Patients who have received filgrastim within 24 hours prior to enrollment\n* Patients who have received pegfilgrastim within 14 days prior to enrollment\n* Hypersensitivity reaction to filgrastim or any related product\n* Patients who have taken lithium within 7 days of enrollment\n* Serum Creatinine \\> 1.5 mg/dL\n* Patients who are pregnant or breastfeeding\n* Patients who are unable to understand and/or render informed consent'}, 'identificationModule': {'nctId': 'NCT01719432', 'briefTitle': 'Effect of Body Mass on Filgrastim Pharmacokinetics', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Effect of Body Mass on Filgrastim Pharmacokinetics', 'orgStudyIdInfo': {'id': 'WVU 021112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients'}, {'label': 'Non-obese patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Mary Babb Randolph Cancer Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Aaron Cumpston, PharmD, BCOP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aaron Cumpston, PharmD, BCOP', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Specialist - BMT', 'investigatorFullName': 'Aaron Cumpston, PharmD, BCOP', 'investigatorAffiliation': 'West Virginia University'}}}}