Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430469
Status:
WITHDRAWN
Last Update Posted:
2015-06-30
First Post:
2007-02-01
Brief Title:
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
Official Title:
Safety of a 05mg Dose of hLF1-11 Given for 10 Consecutive Days to Autologous Haematopoietic Stem Cell Transplant Recipients
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic company decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing but have not yet developed infectious complications due to invasive fungal or bacterial disease These patients are different from healthy volunteers because they have received myeloablative treatment which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections which typically occur during the week after transplant It is therefore essential to know that hLF 1-11 is safe and well tolerated when given during neutropenia and mucosal barrier injury before infections ensue
Detailed Description:
Human lactoferrin hLF is a glycoprotein containing 692 amino acids and found in the saliva milk tears and other body fluids The peptide representing the first cationic domain ie the peptide comprising the first eleven residues of hLF further referred to as hLF1-11 was significantly more effective than the full length protein or the peptide representing the second cationic domain As with other antimicrobial peptides hLF1-11 shows poor antimicrobial activity under physiological conditions in vitro but it is highly effective in vivo against infections due to a variety of microorganisms including Gram negative and Gram positive bacteria and fungi The objective is to develop hLF1-11 for the treatment of fungal and bacterial infections that develop during neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplantHSCT formerly referred to as bone marrow transplant Rates of infection and related morbidity are high in this population making it an attractive target for testing clinically the proof-of-principle that hLF1-11 can provide effective treatment Subsequently hLF1-11 will be developed further as a systemic antifungal agent
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 |
|---|---|---|---|
| 2006-004012-52 | EUDRACT_NUMBER | None | None |