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 - ND

• Conditions: mucocopolysaccharidoses I; MedDRA version: 9.1Level: LLTClassification code 10056886

• Registration Number: EUCTR2007-007003-33-IT
• Lead Sponsor: Genzyme Europe BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Mothers must meet the following criteria: 1. Be pregnant, planning to breastfeed postpartum, and receiving Aldurazyme while breastfeeding. 2. Provide signed, written informed consent prior to any protocol-related procedures. Consent of a legally authorized guardian is required for mothers younger than 18 years of age. If a mother is younger than 18 years of age and can understand the consent, written informed consent is required from both the mother and the authorized guardian. 3. Provide signed, written informed consent for their infants to participate as study subjects. If a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Mothers (and their infants) will be excluded from this study if any of the following exclusion criteria are met: 1. Are unwilling to breastfeed. 2. 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. 3. Have an acute illness that requires surgical intervention, and/or anticipates surgery during study participation. 4. Have received an investigational drug within 30 days prior to study enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified