Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326157
Status:
COMPLETED
Last Update Posted:
2010-02-12
First Post:
2006-05-10
Brief Title:
PROPHESSOR AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase II Pilot Study on Safety of Administration of 3mgkgDay Three Times a Week Until Day 22 21 Days After Transplantation Day and 7 mgkg Weekly From Day 29 to the End of Treatment Day 50-8th Week of AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation
Status:
COMPLETED
Status Verified Date:
2010-02
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 pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease GvHD which are both high risk periods as far as severe fungal infection development is concerned
Detailed Description:
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD which are both high risk periods as far as severe fungal infection development is concerned
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