Study on Mannan Binding Lectin (MBL) Substitution in MBL-Deficient Children With Chemotherapy-Induced Neutropenia

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The pharmacokinetics, and clinical and biological effects of MBL replacement therapy in MBL-deficient children during chemotherapy-induced neutropenia were studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Collaborators: Landsteiner Foundation Blood Research (LSBR), Amsterdam; Landsteiner Foundation for Blood Transfusion
• Treatments: Lectins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.