EUCTR2006-001910-33-GB进行中（未招募）不适用
A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants - Effects of Fabrazyme Treatment on Lactation and Infants
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •Inclusion Criteria - Mothers must meet the following criteria to be enrolled in this study:
- •1. provide signed written informed consent to participate in this study,
- •2. be enrolled in the Fabry Registry and receiving Fabrazyme while lactating,
- •3. agree to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
- •4. agree to adhere to the schedule of evaluations for this study.
- •Inclusion Criteria - Infants must meet the following criteria to be enrolled in this study:
- •1. have the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
- •2. be born to a mother who is receiving Fabrazyme during lactation,
- •3. be receiving breast milk from the mother, and
- •4. have the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The mother and infant will be excluded from this study if the mother has received an investigational drug within 30 days prior to study enrollment.
研究者
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