Primary antibody deficiency: - Unclassified antibody deficiency (unPAD) - IgA deficiency - Specific polysaccharide antibody deficiency (SPAD) - IgG subclass deficiency (IgSD) - Common variable immunodeficiency (CVID) - Agammaglobulinemia (X-linked or otherwise)
Conditions
Brief summary
Difference in mean AD and ILD scores (as measured with CT scanning) between t=0 and t=2 years in patients with standard vs higher Ig replacement therapy dosing.
Detailed description
Number of upper- and lower respiratory tract infections before onset of study and during study, i.e.: Sino pulmonary disease, otitis, pneumonia, collected by study CRF's., Pulmonary symptoms will be evaluated on a daily basis (during two periods of 2 months) using a diary that can be directly entered in Castor., Days missed from school and work due to infections, measured by the PCQ (productivity cost questionnaire) instrument., Quality of life, measured with the EQ-5D questionnaire, Ig dosing and IgG trough levels in intervention and in control group, Total health costs (consisting of costs for health care professional visits, medication, hospitalizations, imaging and biochemical investigations) in intervention and control group, collected from electronic patient files., Immunological laboratory phenotype, collected from electronic patient files., Adverse events: reporting and monitoring of patients and Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) will be done by an independent monitor.
Interventions
DRUGGammanorm
DRUG165 mg/ml
DRUGoplossing voor injectie
DRUGCUTAQUIG 165 mg/mL
DRUGsolution injectable
DRUGGAMMAGARD S/D 5
DRUG0 g
DRUGpoeder en oplosmiddel voor oplossing voor infusie.
DRUGOctagam 10%
DRUGCuvitru 200 mg/ml oplossing voor subcutane injectie
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean AD and ILD scores (as measured with CT scanning) between t=0 and t=2 years in patients with standard vs higher Ig replacement therapy dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of upper- and lower respiratory tract infections before onset of study and during study, i.e.: Sino pulmonary disease, otitis, pneumonia, collected by study CRF's., Pulmonary symptoms will be evaluated on a daily basis (during two periods of 2 months) using a diary that can be directly entered in Castor., Days missed from school and work due to infections, measured by the PCQ (productivity cost questionnaire) instrument., Quality of life, measured with the EQ-5D questionnaire, Ig dosing and IgG trough levels in intervention and in control group, Total health costs (consisting of costs for health care professional visits, medication, hospitalizations, imaging and biochemical investigations) in intervention and control group, collected from electronic patient files., Immunological laboratory phenotype, collected from electronic patient files., Adverse events: reporting and monitoring of patients and Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpecte | — |
Countries
Netherlands
Outcome results
None listed