Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138736
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2005-08-29
Brief Title:
Study on Mannan Binding Lectin MBL Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
Sponsor:
Prothya Biosolutions
Organization:
Prothya Biosolutions
Study Overview
Official Title:
Phase II Study on Mannan Binding Lectin MBL Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
Status:
COMPLETED
Status Verified Date:
2007-08
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 pharmacokinetics and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied
Detailed Description:
Mannan Binding Lectin MBL is a member of the lectin pathway of the complement system and plays an important role in the innate immune system MBL replacement in MBL-deficient children with chemotherapy-induced neutropenia represents a new approach to lower the risk of febrile episodes of hospital admission of prolonged use of intravenous antibiotics and of severe infections
The aim of the Phase II study is to find evidence for the correct prediction of plasma levels of MBL necessary for clinical effects and biological efficacy to confirm the dosage regimen needed to reach the required MBL plasma levels and reconfirm the safety and lack of side-effects
The aim of the Phase II study is to find evidence for the correct prediction of plasma levels of MBL necessary for clinical effects and biological efficacy to confirm the dosage regimen needed to reach the required MBL plasma levels and reconfirm the safety and lack of side-effects
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