Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03029000
Status:
TERMINATED
Last Update Posted:
2022-12-13
First Post:
2017-01-19
Brief Title:
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
Sponsor:
Teva Branded Pharmaceutical Products RD Inc
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Single-Arm Study of the Effect of a 5-day Regimen of Tbo-Filgrastim 10 mcgkg of Body Weight Administered Subcutaneously on Peripheral Stem Cell Mobilization in Healthy Donors
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRANIX
Brief Summary:
A multi-center open-label single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram mcgkg of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34 CD34 cells in at least 60 healthy male and female participants The pharmacokinetics pharmacodynamics safety tolerability and immunogenicity of tbo-filgrastim will be assessed
Detailed Description:
None
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