Status:
TERMINATED
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Alpha Galactosidase A Deficiency
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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
- The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
Key Trial Info
Start Date :
May 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00230607
Start Date
May 28 2006
End Date
February 9 2024
Last Update
April 10 2024
Active Locations (5)
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1
Investigational Site Number 840005
Decatur, Georgia, United States, 30033
2
Investigational Site Number 840006
Fairfax, Virginia, United States, 22030
3
investigational site number 01Rhead
Milwaukee, Wisconsin, United States, 53201-1997
4
investigational site number 04Bodamer
Marl, Austria