A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants

Update Il y a 4 ans
Reference: EUCTR2006-001910-33

Woman and Man

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Extract

The objectives of this study are: 1. To determine whether alpha-GAL activity is present in the breast milk of mothers with Fabry disease who are being treated with Fabrazyme during lactation. 2. To measure breast milk production and composition (volume, protein and fat content) in women with Fabry disease who receive Fabrazyme during lactation. 3. To determine whether Fabrazyme affects the growth, development, and immunologic response of infants born to mothers with Fabry disease who receive Fabrazyme during lactation.


Inclusion criteria

  • Fabry Disease