EUCTR2007-007003-33-IT进行中（未招募）不适用
A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme(laronidase) Treatment on Lactation in Women with Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants - ND
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
- Female
入选标准
- •Mothers must meet the following criteria: 1. Be pregnant, planning to breastfeed postpartum, and receiving Aldurazyme while breastfeeding. 2. Provide signed, written informed consent prior to any protocol-related procedures. Consent of a legally authorized guardian is required for mothers younger than 18 years of age. If a mother is younger than 18 years of age and can understand the consent, written informed consent is required from both the mother and the authorized guardian. 3. Provide signed, written informed consent for their infants to participate as study subjects. If a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian.
- •Are the trial subjects under 18? no
- •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
- •Mothers (and their infants) will be excluded from this study if any of the following exclusion criteria are met: 1. Are unwilling to breastfeed. 2. Have a medical condition, serious intercurrent illness, or other extenuating circumstance that may interfere with study compliance, including all prescribed evaluations and follow-up activities. 3. Have an acute illness that requires surgical intervention, and/or anticipates surgery during study participation. 4. Have received an investigational drug within 30 days prior to study enrollment.
研究者
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