Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413439
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2006-12-18
Brief Title:
Safety Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Sponsor:
Basilea Pharmaceutica
Organization:
Basilea Pharmaceutica
Study Overview
Official Title:
Open Label Multi-center Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections The study investigates the safety and tolerability of two different dosages the efficacy in prevention of fungal diseases
Detailed Description:
Patients with Acute Myeloid Leukemia who undergo aggressive chemotherapy are due to immunosuppression susceptible to infections including fungal infections As the failure rate in the treatment of invasive fungal infections is high prophylaxis is frequently recommended This open label study investigates the safety and tolerability of two different dosages of a water soluble azole antifungal as well as the efficacy in prevention of invasive fungal infections and pharmacokinetic data
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 |
|---|---|---|---|
| 2005-005294-30 | EUDRACT_NUMBER | None | None |