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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: Sanofi
ClinicalTrials.gov processed this data on November 27, 2014
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, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

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: August 11, 2014

Page last updated: November 27, 2014

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