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Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Clinique Rambot La Provençale Tour d'Aygosi
Aix En Provence, , 13100 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chemotherapy-Induced Neutropenia
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

- Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid
tumour.

- Patients for whom the oncologist has decided the initiation of G-CSF biosimilar
treatment (Nivestim®) in primary or secondary prophylaxis.

- Patients informed about the computer processing of their medical data and their right
of access and correction.

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

- Patients with contraindication of use of Nivestim®.

- Patients with haematological malignancy including Myelodysplasia and Chronic myeloid
leukemia treated or untreated.

- Patients participating or having participated in the previous month in a clinical
trial.

- Patients refusing to participate in this study.

NCT02454530
Pfizer
Completed
Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study

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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.
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with solid tumour treated with cytotoxic chemotherapy and for whom a prophylactic treatment with G-CSF biosimilar (Nivestim®) is initiated
Chemotherapy-Induced Neutropenia
Biological: Nivestim®
Cancer patients treated with Nivestim®
Intervention: Biological: Nivestim®
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1154
February 2017
October 18, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
  • Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
  • Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

  • Patients with contraindication of use of Nivestim®.
  • Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
  • Patients participating or having participated in the previous month in a clinical trial.
  • Patients refusing to participate in this study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02454530
VISTA
C1121007 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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