Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
NCT02956967
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Adult Trials: 18+ Years
- 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
- 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
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| 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 | 171 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2018 | |||