antibody deficiency
Conditions
Interventions
In the study period that patients are treated with intravenous immunoglobulin,
Nanogam will be administered in the following dosages:
• Adults: 600 mg/kg bodyweight every 3 weeks
• Children: 800 mg/k
Sponsors
Sanquin Plasmaproducten
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency, and at least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.
Exclusion criteria
Exclusion criteria: - Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study - Allergic reactions against human plasma/plasma products, or co-trimoxazol - An ongoing progressive terminal disease - Pregnancy or lactation - Renal insufficiency (plasma creatinin > 115 µmol/L; or creatinin clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical efficacy parameters are: the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements. | — |
Countries
Netherlands
Outcome results
None listed