A Study of the Effects of Fabrazyme (Agalsidase Beta) on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fabry Disease
Intervention: agalsidase beta (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Genzyme, a Sanofi Company Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company
Overall contact: Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com
Summary
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.
Clinical Details
Official title: A Multicenter, Multinational Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Presence of alpha-galactosidase (αGAL) activity in breast milk of mothers who are being treated with Fabrazyme (agalsidase beta) during lactationGrowth and development of infants born to mothers who have received Fabrazyme (agalsidase beta) treatment during lactation Volume, total fat and protein content in breast milk of mothers who are being treated with Fabrazyme (agalsidase beta) during lactation Pharmacokinetics: Milk αGAL to plasma αGAL ratio Formation or continued presence of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to α-galactosidase A (r-hαGAL) in infants receiving breast milk from mothers treated with Fabrazyme (agalsidase beta) during lactation
Detailed description:
NOTE: Estimated Enrollment: 10 mothers and up to 10 infants
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com
Salzburg, Austria; Completed
Salford, United Kingdom; Completed
Participation in this study is not limited to this facility; facilities not yet active may enroll upon identification of a patient, Cambridge, Massachusetts, United States; Recruiting
Dallas, Texas, United States; Terminated
Milwaukee, Wisconsin, United States; Completed
Additional Information
Starting date: August 2006
Last updated: April 7, 2015
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