EUCTR2006-005215-98-NL
Active, not recruiting
Not Applicable
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 Response
Sanquin Plasma Products0 sitesAugust 9, 2007
ConditionsEstablished diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.MedDRA version: 8.1Level: LLTClassification code 10021275Term: IgG subclass deficiency
DrugsNanogam
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Established diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.
- Sponsor
- Sanquin Plasma Products
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (\= 18 years of age), IUWP2005\.01A, Children (\= 5\-18 years of age), IUWP2005\.01B
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
- •Known with allergic reactions against human plasma or plasma products, or allergy against co\-trimoxazol
- •an ongoing progressive terminal disease, including HIV infection
- •Pregnancy or lactation
- •Previous history of (transient) cerebrovascular accident or coronary insufficiency.
- •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 complains.
- •detectable anti\-IgA antibodies
- •active SLE
- •Known with glucose\-6\-phosphate hydrogenase deficiency
Outcomes
Primary Outcomes
Not specified
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