Last updated on June 2016

A Study of the Effects of Fabrazyme (Agalsidase Beta) on Mother's Lactation and on the Growth Development and Immunologic Response of Their Infants


Brief description of study

The purpose of this study is to observe the potential effects of Fabrazyme (agalsidase beta) 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. There are 3 participation scenarios: mother/infant full participation, mother full participation/infant development assessment only, and mother full participation/infant no participation. Whether or not the mother continues to lactate will be assessed at each visit. If the mother is no longer lactating, the mother will discontinue this study but continue to be followed in the Fabry Registry. The infant (if participating) will be followed for development only for the remainder of this 24 month study.

Detailed Study Description

NOTE: Estimated Enrollment: 10 mothers and up to 10 infants

Clinical Study Identifier: NCT00230607

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Participation in this study is not limited to this facility; facilities not yet active may enroll upon identification of a patient
Cambridge, MA United States
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Dallas, TX United States
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Milwaukee, WI United States
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Salford, United Kingdom
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