Trials / Terminated
TerminatedNCT02454530
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study
PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,160 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.
Detailed description
This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists. Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations: * Baseline visit: prescription of Nivestim®. * Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®. * Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivestim® |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-10-18
- Completion
- 2017-01-01
- First posted
- 2015-05-27
- Last updated
- 2019-06-28
- Results posted
- 2019-06-28
Locations
92 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02454530. Inclusion in this directory is not an endorsement.