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A Study of the Effects of Fabrazyme on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants - NCT00230607-53201(Clinical Trial 131416)



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City:  Milwaukee
State:  
WI
Zip Code: 53201
Conditions: Fabry Disease
Purpose: The purpose of this study is to observe the potential effects of Fabrazyme treatment on lactation and on the growth, development, and immunologic response of infants born to mothers with Fabry disease who are treated with Fabrazyme during lactation.
Study summary: NOTE: Estimated Enrollment: 10 mothers and up to 10 infants
Criteria: Inclusion Criteria: - Mother must provide signed written informed consent to participate in this study. - Mother must be enrolled in the Fabry Registry and receiving Fabrazyme while lactating. - Mother must agree to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing. - Mother must agree to adhere to the schedule of evaluations for this study. - Infant must have the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study. - Infant must be born to a mother who is receiving Fabrazyme during lactation. - Infant must be receiving breast milk from the mother. - Infant must have 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 will be excluded from this study if the mother has received an investigational drug within 30 days prior to study enrollment.
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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