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

• Conditions: Established diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.; MedDRA version: 8.1Level: LLTClassification code 10021275Term: IgG subclass deficiency

• Registration Number: EUCTR2006-005215-98-NL
• Lead Sponsor: Sanquin Plasma Products

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified