Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509938
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2007-07-31
Brief Title:
Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients
Sponsor:
AM-Pharma
Organization:
AM-Pharma
Study Overview
Official Title:
Safety and Efficacy of Human Lactoferrin hLF1-11 for the Treatment of Infectious Complications Among Haematopoietic Stem Cell Transplant Recipients Part A Clinical Study Protocol SC12 Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2008-10
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:
The safety and tolerability of hLF 1-11 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 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 when given during neutropenia and mucosal barrier injury before infections ensue
Detailed Description:
Background
Human lactoferrin hLF is a glycoprotein containing 692 amino acids and found in the saliva milk tears and other body fluids Peptide representing the first cationic domain ie a peptide comprising the first eleven residues of hLF further referred to as hLF1-11 was significantly more effective than the full length hLF or the peptide representing the second cationic domain in killing a variety of bacteria in vivo The mechanism of action comprises a number of independent factors The classical way to explain the efficacy is the direct killing effect which typically is observed in vitro at relatively high concentrations The results of in vitro and in vivo experiments suggest that the mechanism of action is predominantly through the intermediary of cells andor components of the host as opposed to a direct interaction with the pathogen
The objective is to develop hLF1-11 as an effective and safe antibacterial and antifungal for the treatment of fungal and bacterial infections that develop during the neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplant HSCT 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 provided effective treatment Subsequently hLF1-11 will be developed further as a systemic antifungal agent
Human lactoferrin hLF is a glycoprotein containing 692 amino acids and found in the saliva milk tears and other body fluids Peptide representing the first cationic domain ie a peptide comprising the first eleven residues of hLF further referred to as hLF1-11 was significantly more effective than the full length hLF or the peptide representing the second cationic domain in killing a variety of bacteria in vivo The mechanism of action comprises a number of independent factors The classical way to explain the efficacy is the direct killing effect which typically is observed in vitro at relatively high concentrations The results of in vitro and in vivo experiments suggest that the mechanism of action is predominantly through the intermediary of cells andor components of the host as opposed to a direct interaction with the pathogen
The objective is to develop hLF1-11 as an effective and safe antibacterial and antifungal for the treatment of fungal and bacterial infections that develop during the neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplant HSCT 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 provided 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 |
|---|---|---|---|
| IS 044096 | None | None | None |
| SC12 | None | None | None |