Status:
COMPLETED
Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia
Lead Sponsor:
Prothya Biosolutions
Collaborating Sponsors:
Landsteiner Foundation for Blood Transfusion
Conditions:
MBL-Deficient
Neutropenia
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
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 chemother...
Eligibility Criteria
Inclusion
- Children ages 0 - 12 years, during chemotherapy, and expected to become neutropenic
- MBL deficiency by genotype or phenotype (\< 100 ng/ml)
- Informed consent and assent of patient and/or legal representative
Exclusion
- Inability or unwillingness to comply with the protocol or likely inability to complete the study period
- Known allergic reactions to MBL and other human plasma products
- Participation in other investigational drug studies within the last month
- Clinically relevant abnormalities in: serum immunoglobulins IgG, IgA, IgM; blood counts; complement factors measured by AP50, CH50; urine protein and cell counts; serum creatinine and liver enzymes, as routinely determined for regular patient care.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00138736
Start Date
April 1 2004
End Date
October 1 2006
Last Update
August 30 2007
Active Locations (2)
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1
Academic Medical Centre
Amsterdam, Netherlands, 1105 AZ
2
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 GD