Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Stopped early · Phase 4
Conditions studied: Fabry Disease, Alpha Galactosidase A Deficiency
In brief
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.
Key facts
- Study ID
- NCT00230607
- Run by
- Genzyme, a Sanofi Company
- People needed
- 7
- Starts
- 2006-05-28
- Expected to finish
- 2024-02-09
- Last updated by the study team
- 2024-04-10
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
Where it is running
- Investigational Site Number 840005 — Decatur, Georgia, United States
- Investigational Site Number 840006 — Fairfax, Virginia, United States
- investigational site number 01Rhead — Milwaukee, Wisconsin, United States
- investigational site number 04Bodamer — Marl, Austria
- investigational site number 03Waldek — Salford, United Kingdom
Full record on ClinicalTrials.gov
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