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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Office of Manfred Welslau
Aschaffenburg, , 63739 Germany
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleHome Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Official TitleHome 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 SummaryNon-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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAdults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.
ConditionNon-Interventional Study
InterventionOther: Overall satisfaction questionnaires of home use of Nivestim
Study Groups/CohortsPatients 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 StatusCompleted
Actual Enrollment
 (submitted: March 14, 2017)
171
Original Estimated Enrollment
 (submitted: November 3, 2016)
500
Actual Study Completion DateDecember 12, 2016
Actual Primary Completion DateDecember 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02956967
Other Study ID NumbersZOB-NIV-1504
C1121004 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

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