NL-OMON35384
Completed
Phase 4
Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response. - Treatment of deficient subclass and/or antipolysaccharide antibody response
Sanquin Plasmaproducten0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- antibody deficiency
- Sponsor
- Sanquin Plasmaproducten
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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 \<20 ml/min))
- •\- An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints
- •\- Detectable anti\-IgA antibodies
- •\- Active SLE
- •\- Glucose\-6\-phosphate hydrogenase deficiency
Outcomes
Primary Outcomes
Not specified
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Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response. - Treatment of IgG Subclass Deficiency and/or Deficiency of Anti-Polysaccharide Antibody ResponseEstablished diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.MedDRA version: 8.1Level: LLTClassification code 10021275Term: IgG subclass deficiencyEUCTR2006-005215-98-NLSanquin Plasma Products
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