Clinical Trial: Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Home Administration Of Nivestimtm In The Primary Prophylaxis Of Chemotherapy-induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home

Brief Summary: Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Mean age of patients enrolled [ Time Frame: Baseline ]
  • Percentage of patients enrolled with any previous or ongoing significant comorbidities [ Time Frame: Baseline ]
  • Percentage and type of haematological malignancy diagnosed [ Time Frame: Baseline ]
  • Percentage and type of solid tumor diagnosed [ Time Frame: Baseline ]
  • Mean time since diagnosis of solid tumour or malignant haematological tumour prior to enrollment [ Time Frame: Baseline ]
  • percentage of males and females enrolled [ Time Frame: Baseline ]
  • Mean weight of patients enrolled [ Time Frame: Baseline ]
  • Mean body mass index (BMI) of patients enrolled [ Time Frame: Baseline ]
  • Number of patients receiving chemotherapy prior to enrollment [ Time Frame: Baseline ]
  • Mean duration and type of chemotherapy received during study [ Time Frame: Baseline up to approximately 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of patients who have a positive satisfaction with Nivestim [ Time Frame: Baseline up to approximately 6 months ]
  • Patients' overall rating of satisfaction with Nivestim [ Time Frame: Baseline up to approximately 6 months ]
  • Patient assessment of Nivestim packaging [ Time Frame: Baseline up to approximately 6 months ]
    Evaluation of Nivestim™ packaging Nivestim™ handling instructions Manageability of Nivestim™ syringes
  • Patient assessment of tolerability of Nivestim at the injection site [ Time Frame: Baseline up to 6 months ]
    Patients' rating of Tolerability of Nivestim™ at the injection site Painfulness of the needle insertion into the skin Overall tolerability of the subcutaneous injection of Nivestim™
  • Percentage of patients who experience neutropenia [ Time Frame: Baseline up to approximately 6 months ]
  • Percentage of patients who experience an infection [ Time Frame: Baseline up to approximately 6 months ]
  • Change from baseline in absolute neutrophil count [ Time Frame: Baseline up to approximately 6 months ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: November 3, 2016
Date Started: September 23, 2015
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017