This study is currently not recruiting participants.

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

Investigational Study on Lactation in Women with MPS I

Not Recruiting
Female
Phase 4
2 participants needed

Study Overview

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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie
  • Gender: Female

Inclusion Criteria (Mothers):

  • The patient must have a documented laronidase deficiency with a fibroblast, plasma, serum, leukocyte, or dried blood spot laronidase enzyme activity assay.
  • Be pregnant, planning to breastfeed post-partum, and receiving Aldurazyme (laronidase) therapy while breastfeeding.
  • Provide signed, written informed consent prior to any protocol-related procedures. Consent of a legally authorized guardian(s) is (are) required for mothers younger than 18 years of age. If a mother is under 18 years old and can understand the consent, written informed consent is required from both the mother and the authorized guardian(s).
  • Provide signed, written informed consent for their infants to participate as study patients. If a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian.

Exclusion Criteria (Mothers and Infants):

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

This study investigates the presence of an investigational medication in the breast milk of women with Mucopolysaccharidosis I (MPS I) and its effects on the growth and development of breastfed infants.

  • Who can participate: Women with a documented laronidase deficiency who are pregnant and plan to breastfeed while receiving the investigational medication can participate. Participants must provide informed consent, and if under 18, consent from a legal guardian is also required.
  • Study details: Participants will receive the investigational medication while breastfeeding. The study will check if the medication is in the breast milk and observe its effects on the infants.
Updated on 20 Feb 2024. Study ID: NCT00418821