Neutropenia Clinical Trial
Official title:
Phase II Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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