Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01079676
Status:
COMPLETED
Last Update Posted:
2012-10-16
First Post:
2010-03-02
Brief Title:
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Phase III Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product
Detailed Description:
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product For this the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy according to the classification Common Terminology Criteria for Adverse Events CTC-AE
The study secondary objectives will be to compare other efficacy aspects as well as the tolerability of the two products containing filgrastim
The secondary endpoints considered for the study will be
The febrile neutropenia rate
The rate of any grade 4 neutropenia
The duration of the grade 4 neutropenia
The frequency of the adverse events and the laboratory changes
The study secondary objectives will be to compare other efficacy aspects as well as the tolerability of the two products containing filgrastim
The secondary endpoints considered for the study will be
The febrile neutropenia rate
The rate of any grade 4 neutropenia
The duration of the grade 4 neutropenia
The frequency of the adverse events and the laboratory changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None