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Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

NCT04971304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16506

Last updated 2023-07-27

No results posted yet for this study

Summary

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

Conditions

  • Cancer, Breast
  • Cancer, Lung
  • Cancer of Colon
  • Cancer of Pancreas
  • Cancer, Ovarian
  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Receipt of granulocyte-colony stimulating factor

Receipt of originator or biosimilar

Sponsors & Collaborators

  • Harvard Pilgrim Health Care

    collaborator OTHER

  • HealthPartners Institute

    collaborator OTHER

  • Catherine M. Lockhart

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2022-09-30
Completion
2022-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971304 on ClinicalTrials.gov