DRKS00003877已完成不适用
Post-Authorisation Surveillance Safety study with Flebogamma DIF100 mg/ml and Flebogamma DIF50 mg/ml
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 Years 至 one（—）
- 性别
- All
入选标准
- •1.Male or female aged 2 years or more
- •2.The subject is treated with Flebogamma DIF100 mg/ml or Flebogamma DIF50 mg/ml according to the prescribing physician and the SPC.
- •3.The subject freely gives written informed consent.
排除标准
- •1. The subject is known to have history of intolerance to any Flebogamma DIFcontaining substances such as sorbitol (e.g. intolerance to fructose).
- •2. The subject is known to have history of anaphylactic reaction(s) to blood or blood components.
- •3. Has been diagnosed with IgA deficiency and has antibodies anti-IgA.
- •4. The subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks.
- •5. The subject is unlikely to adhere to the protocol requirements of the study
研究者
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