NCT00418821

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 description

Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient.

Conditions

• Mucopolysaccharidosis I
• Hurler's Syndrome
• Hurler-Scheie Syndrome
• Scheie

Interventions

Type	Name	Description
BIOLOGICAL	Laronidase	dose of 0.58mg/kg body weight intravenously (IV) every week

Timeline

• Start date: 2010-10-22
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2007-01-05
• Last updated: 2024-02-20
• Results posted: 2024-02-20

Locations

1 site across 1 country: Italy