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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956967
Recruitment Status : Completed
First Posted : November 6, 2016
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 3, 2016
First Posted Date November 6, 2016
Results First Submitted Date December 11, 2017
Results First Posted Date February 11, 2019
Last Update Posted Date February 11, 2019
Actual Study Start Date September 23, 2015
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2018)
  • Percentage of Participants With Any Significant Comorbidities [ Time Frame: Baseline (Day 1) ]
    Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.
  • Percentage of Participants With Different Types of Haematological Malignancies [ Time Frame: Baseline (Day 1) ]
    Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.
  • Percentage of Participants With Different Types of Solid Tumour [ Time Frame: Baseline (Day 1) ]
    Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.
  • Duration of Solid Tumour in Participants Prior to Enrolment in Study [ Time Frame: Baseline (Day 1) ]
    Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.
  • Number of Participants Who Received Chemotherapy Prior to Enrolment in Study [ Time Frame: Baseline (Day 1) ]
  • Duration of Different Types of Chemotherapies Received by Participants During Study [ Time Frame: Baseline up to 6 months ]
  • Percentage of Participants With Response to Study Treatment [ Time Frame: Baseline up to 6 months ]
Original Primary Outcome Measures
 (submitted: November 3, 2016)
  • 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 ]
Change History
Current Secondary Outcome Measures
 (submitted: September 18, 2018)
  • Participants' Overall Satisfaction Scores in Response to the Study Treatment [ Time Frame: Baseline up to 6 months ]
    Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.
  • Participant's Assessment for Nivestim Packaging [ Time Frame: Baseline up to 6 months ]
    Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
  • Participant's Assessment of Injection Site Pain and Tolerability [ Time Frame: Baseline up to 6 months ]
    Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.
  • Participant's Assessment of Overall Tolerability of Subcutaneous Injection [ Time Frame: Baseline up to 6 months ]
    Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
  • Percentage of Participants With Neutropenia [ Time Frame: Baseline up to 6 months ]
    Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.
  • Percentage of Participants With at Least One Infection and Serious Infection [ Time Frame: Baseline up to 6 months ]
    Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 [ Time Frame: Baseline, Cycle 1, 2, 3, 4, 5, 6 ]
  • Minimum Value of Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
  • Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle [ Time Frame: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6) ]
  • Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
  • Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count [ Time Frame: Cycle 1, 2, 3, 4, 5, 6 ]
  • Percentage of Participants With Febrile Neutropenia [ Time Frame: Baseline up to 6 months ]
    Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and absolute neutrophil count of less than (<) 1.0 × 10^9 Neutrophils per Liter.
Original Secondary Outcome Measures
 (submitted: November 3, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2018)		 Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 6 months ]
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Official Title Home Administration Of Nivestim(tm) In The Primary Prophylaxis Of Chemotherapy- Induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.
Condition Non-Interventional Study
Intervention Other: Overall satisfaction questionnaires of home use of Nivestim
Study Groups/Cohorts Patients receiving Nivestim
Intervention: Other: Overall satisfaction questionnaires of home use of Nivestim
Publications * Otremba B, Hielscher C, Petersen V, Petrik C. Home administration of filgrastim (Nivestim) in primary prophylaxis of chemotherapy-induced febrile neutropenia. Patient Prefer Adherence. 2018 Oct 16;12:2179-2186. doi: 10.2147/PPA.S168029. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2017)		 171
Original Estimated Enrollment
 (submitted: November 3, 2016)		 500
Actual Study Completion Date December 12, 2016
Actual Primary Completion Date December 12, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male and female patients ≥ 18 years
  • Declaration of informed consent signed by patient
  • Patients with a solid tumour or with a malignant haematological tumour
  • Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
  • GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
  • Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN

Exclusion Criteria:

  • Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
  • Patients who are hypersensitive to one of the excipients of NivestimTM
  • Patients not undergoing chemotherapy
  • Patients being treated curatively or as secondary prophylaxis with G-CSF
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02956967
Other Study ID Numbers ZOB-NIV-1504
C1121004 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor Pfizer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018