跳至主要内容
临床试验/EUCTR2006-005215-98-NL
EUCTR2006-005215-98-NL进行中(未招募)不适用

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 个研究点开始时间: 2007年8月9日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Sanquin Plasma Products

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