A Study of the Effects of Fabrazyme (Agalsidase Beta) on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology, Metabolic |
| Therapuetic Areas: | Hematology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2006 |
| End Date: | January 2020 |
| Contact: | Medical Information |
| Email: | medinfo@genzyme.com |
| Phone: | 800-745-4447 |
A Multicenter, Multinational Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants
The purpose of this study is to observe the potential effects of Fabrazyme (agalsidase beta)
treatment on lactation and on the growth, development, and immunologic response of infants
born to mothers with Fabry disease who are treated with Fabrazyme during lactation. There
are 3 participation scenarios: mother/infant full participation, mother full
participation/infant development assessment only, and mother full participation/infant no
participation. Whether or not the mother continues to lactate will be assessed at each
visit. If the mother is no longer lactating, the mother will discontinue this study but
continue to be followed in the Fabry Registry. The infant (if participating) will be
followed for development only for the remainder of this 24 month study.
treatment on lactation and on the growth, development, and immunologic response of infants
born to mothers with Fabry disease who are treated with Fabrazyme during lactation. There
are 3 participation scenarios: mother/infant full participation, mother full
participation/infant development assessment only, and mother full participation/infant no
participation. Whether or not the mother continues to lactate will be assessed at each
visit. If the mother is no longer lactating, the mother will discontinue this study but
continue to be followed in the Fabry Registry. The infant (if participating) will be
followed for development only for the remainder of this 24 month study.
NOTE: Estimated Enrollment: 10 mothers and up to 10 infants
Inclusion Criteria:
- Mother must provide signed written informed consent to participate in this study.
- Mother must be enrolled in the Fabry Registry and receiving Fabrazyme (agalsidase
beta) while lactating.
- Mother must agree to adhere to the Fabry Registry recommended schedule of assessments
for medical history, pregnancy outcome, genotyping, and antibody testing.
- Mother must agree to adhere to the schedule of evaluations for this study.
- Infant must have the signed written informed consent of the parent(s)/legal
guardian(s) to participate in this study.
- Infant must be born to a mother who is receiving Fabrazyme (agalsidase beta) during
lactation.
- Infant must be receiving breast milk from the mother.
- Infant must 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.
We found this trial at
4
sites
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Cambridge, Massachusetts
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