A Study of the Effect of Aldurazyme� (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
Information source: Genzyme
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie
Intervention: Aldurazyme (laronidase) (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme
Overall contact:
Medical Information, Phone: 800-745-4447, Email: MedInfo@genzyme.com
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Breast milk samples for laronidase, Immunogenicity Testing, and Urinary glycosaminoglycans (uGAG).
Detailed description:
Recruitment is not limited to the facility listed; facilities not yet active may be added
upon identification of a patient.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Medical Information, Phone: 800-745-4447, Email: MedInfo@genzyme.com
Dipartimento di Scienze Pediatriche Medico - Chirurgiche e Neuro Scienze dello Suiluppo, Rome, Italy; Recruiting
Additional Information
Starting date: October 2010
Last updated: January 8, 2013
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