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

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NCT02956967

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Office of Manfred Welslau
Aschaffenburg, , 63739 Germany
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Interventional Study
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02956967
Pfizer
Completed
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

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Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Home Administration Of Nivestimtm In The Primary Prophylaxis Of Chemotherapy-induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Non-Interventional Study
Other: Overall satisfaction questionnaires of home use of Nivestim
Patients receiving Nivestim
Intervention: Other: Overall satisfaction questionnaires of home use of Nivestim
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
December 12, 2016
December 12, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02956967
ZOB-NIV-1504
C1121004 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

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