Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:39 AM
Study NCT ID:
NCT03433560
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2018-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
Sponsor:
Kyowa Kirin Korea Co., Ltd.
Organization:
Study Overview
Official Title:
An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: