Clinical Trial: A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme (Laronidase) Treatment on Lactation in Women With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

Brief Summary: The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic response of their breastfed infants.

Detailed Summary: Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient.
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome: Breast milk samples for laronidase, Immunogenicity Testing, and Urinary glycosaminoglycans (uGAG). [ Time Frame: Up to 18 months ]

Original Primary Outcome: To determine the effect of Aldurazyme® (laronidase) treatment in lactating MPS I patients and the growth, development, and immunologic response of their breastfed infants.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: January 3, 2007
Date Started: October 2010
Date Completion: January 2020
Last Updated: June 22, 2016
Last Verified: June 2016