ALID01803: A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

This study is currently recruiting patients.

Sponsored By:	Biomarin/Genzyme LLC
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00418821

Purpose

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

Condition	Intervention	Phase
Mucopolysaccharidosis I Hurler's Syndrome Hurler-Schei Syndrome Scheie Syndrome	Drug: Aldurazyme	Phase 4

Study Type: Interventional

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

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

Further Study Details:

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

Expected Total Enrollment: 10

Eligibility

Genders Eligible for Study: Female

Criteria

Inclusion Criteria:

Mothers must:

Be pregnant, planning to breastfeed post-partum, and currently receiving Aldurazyme therapy.

Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years. If the patient is under 18 years old and can understand the consent, written informed consent will be required from both the patient and the authorized guardian(s).

Provide signed, written informed consent for their infants to participate as study patients.

Exclusion Criteria:

Mothers will be excluded from this study if they meet any of the following exclusion criteria:

Are unwilling to breastfeed.

Have a medical condition, serious intercurrent illness, or other extenuating circumstance that may interfere with study compliance including all prescribed evaluations and follow-up activities.

Have an acute illness that requires surgical intervention, and/or anticipates surgery during study participation.

Have received an investigational drug within 30 days prior to study enrollment.

Location and Contact Information

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

United States, Massachusetts
Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient., Cambridge, Massachusetts, United States; Recruiting

More Information

US FDA Approved Full Prescribing Information for Aldurazyme®

Study ID Numbers: ALID01803
ClinicalTrials.gov Identifier: NCT00418821
Health Authority: United States: Food and Drug Administration