Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362544
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2006-05-10
Brief Title:
PROPHYSOME Pilot Study on Safety of a Weekly Administration of 10mgkg of AmBisome in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Pilot Study on Safety of a Weekly Administration of 10mgkg of AmBisome in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia
Status:
COMPLETED
Status Verified Date:
2015-07
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 aplastic phase following induction or consolidation chemotherapy for acute leukaemia and during the initial phase of allogeneic stem-cell transplant which are both high risk periods as far as severe fungal infections 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 aplastic phase following induction or consolidation chemotherapy for acute leukaemia and during the initial phase of allogeneic stem-cell transplant which are both high risk periods as far as severe fungal infections 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GS-FR-131-0119 | None | None | None |