Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Fabry Disease, Alpha Galactosidase A Deficiency
About this trial
This is an interventional treatment trial for Fabry Disease focused on measuring alpha Galactosidase A, aGAL, rh aGAL, Fabry, GL3, Fabrazyme, Lysosomal Storage Disorder, Enzyme Replacement Therapy (ERT)
Eligibility Criteria
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.
Sites / Locations
- Investigational Site Number 840005Recruiting
- Investigational Site Number 840006Recruiting
- investigational site number 01Rhead
- investigational site number 04Bodamer
- investigational site number 03Waldek
Arms of the Study
Arm 1
Experimental
Agalsidase beta
Commercially available Fabrazyme treatment at prescribed dose and regimen as determined by their treating physician