Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03511378
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2018-03-20
Brief Title:
Immunogenicity Assessment of Peg-filgrastim vs Neulasta as Adjunct to Chemotherapy in Patients With Breast Cancer
Sponsor:
Lupin Ltd
Organization:
Lupin Ltd
Study Overview
Official Title:
An Open-label Randomized Comparative Parallel Group Study to Assess the Immunogenicity of Lupins Peg-filgrastim Versus Neulasta as an Adjunct to Chemotherapy in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-05
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 study is to compare the immunogenicity of Peg-filgrastim versus Neulasta as an adjunct to chemotherapy in patients with breast cancer
Detailed Description:
An open-label randomized comparative parallel group study to assess the Immunogenicity of Lupins Peg-filgrastim versus Neulasta as an Adjunct to Chemotherapy in Patients with Breast Cancer
Primary Objective To assess the immunogenicity of Lupins Peg-filgrastim with Neulasta in patients with breast cancer
Secondary Objectives To assess the safety of Lupins Peg-filgrastim with Neulasta in patients with breast cancer
Primary Objective To assess the immunogenicity of Lupins Peg-filgrastim with Neulasta in patients with breast cancer
Secondary Objectives To assess the safety of Lupins Peg-filgrastim with Neulasta in patients with breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None