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Study of the Effects of Fabrazyme Treatment on Lactation and Infants

TerminatedPhase 4

Sponsor: Genzyme, a Sanofi Company

Conditions: Fabry Disease, Alpha Galactosidase A Deficiency

Interventions: agalsidase beta

Countries: United States, Austria, United Kingdom

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 overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (5)

Decatur, Georgia, United States
Fairfax, Virginia, United States
Milwaukee, Wisconsin, United States
Marl, Austria
Salford, United Kingdom