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
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