A Phase 2 interventional study of Mannan Binding Lectin (MBL) and Mannan Binding Lectin in MBL-Deficient and Neutropenia, sponsored by Prothya Biosolutions. Completed at 2 sites in Netherlands. Open to participants aged Up to 12 Years. Per ClinicalTrials.gov, last updated 2007-08-30.
Sponsored by Prothya Biosolutions · Phase 2, Interventional, and Prevention
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.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 12 is below the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Prothya Biosolutions is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MBL until the patient's absolute neutrophil count (ANC) is above 500/microL blood.
Drug: Mannan Binding Lectin (MBL) · Drug: Mannan Binding Lectin
MBL dose at a twice weekly dose interval (3 or 4 days): 0.2 mg/kg, for a 3-day interval; 0.3 mg/kg, for a 4-day interval
Also known as: MBL SSI
pharmacokinetics of MBL
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
days of fever
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
days of hospital admission
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
use of antibiotics or antifungal medication
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
number and type of infections
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
MBL-dependent opsonizing capacity in vitro
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
safety and incidence of side effects
Time frame: until the patient's absolute neutrophil count (ANC) is above 500/uL blood.
This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Prothya Biosolutions