Nivestim™ in Treatment of Malignant Diseases

Hospira logo

Hospira

Status

Completed

Conditions

Malignant Haematological Tumour
Solid Tumour
Primary or Secondary Prophylactic Treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT01627990
VENICE

Details and patient eligibility

About

The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.

Full description

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

Enrollment

386 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • No age limit
  • Declaration of informed consent signed by patient or legal guardian
  • Patients with a solid tumour or with a malignant haematological tumour
  • Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
  • Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).

Exclusion criteria

  • Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
  • Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
  • Patients not undergoing chemotherapy
  • Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems