filgrastim, TBO-filgrastim or pegfilgrastim
DrugFirst cycle
Other names: Neupogen, Neulasta, Granix, Zarxio
NCT Number: NCT02921191
Purpose:
With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.
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Notify Me18 year and older
All sexes
Observational
Additional information:
To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During baseline 365 days, any patient with a claim for (or with)
First cycle
Other names: Neupogen, Neulasta, Granix, Zarxio
Time frame: Anticipated completion February 2017
Primary: Incidence of hospitalizations for febrile neutropenia in patients with breast or lung cancer receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF
Time frame: Anticipated completion February 2017
Incidence severe neutropenia (ANC<0.5g/l)
Biologics & Biosimilars Collective Intelligence Consortium
Other
Descriptive Analysis of First-Cycle Prophylactic Use of G-CSF in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated With High Neutropenia Risk Chemotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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