AGAL02603: A Study of the Effects of Fabrazyme on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00230607

Purpose

The purpose of this study to observe the effects of treatment with Fabrazyme on lactation and examine the growth and development of breastfed infants whose mothers are receiving Fabrazyme infusions.

Condition	Intervention	Phase
Fabry Disease	Drug: Fabrazyme (agalsidase beta)	Phase IV

Study Type: Interventional

Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Official Title: A Multi-Center, Multi-National Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants.

Further Study Details:

Primary Outcomes: Is a-galactosidase A is present in the breast milk of mothers with Fabry.; Determine affects on growth, development, and immunologic response of infants born to mothers with Fabry disease being treated or who have received treatment during their pregnancy with Fabrazyme.; Observe the effect of Fabrazyme on lactation.

Expected Total Enrollment: 10

Eligibility

Ages Eligible for Study: Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

The patients (mother and infant) will be excluded from this study if the mother has received an investigational drug within 30 days prior to study enrollment.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00230607

Central Contact:
Medical Information 800-745-4447 medinfo@genzyme.com
Medical Information 617-252-7832 medinfo@genzyme.com

Wisconsin Milwaukee, Wisconsin, 53201, United States, Recruiting

More Information

Fabrazyme® FDA-approved labeling information

Study ID Numbers: AGAL02603
ClinicalTrials.gov Identifier: NCT00230607
Health Authority: United States: Food and Drug Administration