Study of the Effects of Fabrazyme Treatment on Lactation and Infants

  • End date
    Nov 13, 2024
  • participants needed
  • sponsor
    Genzyme, a Sanofi Company
Updated on 13 May 2022
agalsidase beta


The study will last for up to 2 years (24 months). Full participation for both mother and infant is 24 months, full participation of mother and development of infant is 24 months, while full participation of mother and no infant participation is 6 months


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

Condition Fabry Disease, Alpha Galactosidase A Deficiency
Treatment agalsidase beta
Clinical Study IdentifierNCT00230607
SponsorGenzyme, a Sanofi Company
Last Modified on13 May 2022


Yes No Not Sure

Inclusion Criteria

Mothers must meet the following criteria to be enrolled in this study
provide signed written informed consent to participate in this study
be enrolled in the Fabry Registry and receiving Fabrazyme while lactating
agree to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
agree to adhere to the schedule of evaluations for this study
Infants must meet the following criteria to be enrolled in this study
have the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study
be born to a mother who is receiving Fabrazyme during lactation
be receiving breast milk from the mother, and
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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