NL-OMON35384已完成4 期
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 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •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.
排除标准
- •- 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
研究者
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