Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Investigation of Treatment Effects on Lactation and Infants
Study Overview
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full participation of mother and no infant participation was 6 months.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Fabry Disease, Alpha Galactosidase A Deficiency
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Gender: All
Inclusion Criteria:
Mothers that met the following criteria were enrolled in this study:
- provided signed written informed consent to participate in this study,
- be enrolled in the Fabry Registry and received Fabrazyme while lactating,
- agreed to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
- agreed to adhere to the schedule of evaluations for this study.
Infants that met the following criteria were enrolled in this study:
- had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
- born to a mother who was receiving Fabrazyme during lactation,
- received breast milk from the mother, and
- had the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.
Exclusion Criteria:
- The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
This study investigates the effects of an investigational medication on lactation and the health of infants. It focuses on mothers who are part of the Fabry Registry and are receiving treatment while breastfeeding. The study aims to understand how the treatment affects milk production and infant development.
Participants in the study will undergo regular assessments, which include medical history reviews, pregnancy outcomes, genotyping, and antibody testing. Infants will also be evaluated regularly to monitor their development and health status.
- Who can participate: The study includes mothers in a registry for individuals with Fabry disease who are receiving treatment while lactating, and their infants who receive breast milk from them.
- Study details: Participants will adhere to a schedule of evaluations, including medical history and genotyping tests. Infants will be monitored for development while receiving breast milk from mothers undergoing treatment.
- Study timelines: The study will last 24 months.
