Stopped: Study was conducted to fulfill a post marketing commitment (PMC). FDA acknowledged closure of PMC.
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Lactating Women With Serum IgG Antibodies to Laronidase
Timeframe: Up to 18 months
Amount of IgG Antibody Titers to Laronidase in Lactating Women
Timeframe: Baseline and Week 12
Number of Women Who Breastfed
Timeframe: Up to 18 months
Number of Women Who Were Successful at Breastfeeding
Timeframe: Up to 18 months
Number of Women Whose Breast Milk Contains Laronidase
Timeframe: Up to 18 months
Amount of Laronidase in the Breast Milk of Lactating Mothers With Mucopolysaccharidosis I (MPS I) Disease
Timeframe: Up to 18 months
Number of Women With Abnormal Urine Glycosaminoglycans (uGAG) Levels
Timeframe: Up to 18 months
Amount of uGAG in the Urine of Women
Timeframe: Baseline and Week 12
Number of Participants With Medical History of the Mother: Pre-Existing Conditions
Timeframe: Baseline
Physical Examination Findings of the Mother
Timeframe: Up to 18 months
Temperature of the Mother
Timeframe: Baseline and Week 12
Heart Rate of the Mother
Timeframe: Baseline and Week 12
Respiratory Rate of the Mother
Timeframe: Baseline and Week 12
Blood Pressure of the Mother
Timeframe: Baseline and Week 12
Weight of the Mother
Timeframe: Baseline and Week 12
Height of the Mother
Timeframe: Baseline
Number of Infants With Abnormal uGAG Levels
Timeframe: Up to 72 weeks
Amount of uGAG in the Urine of Infants
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, Week 60, and Week 72
Number of Participants With Medical History of the Infant:Pre-Existing Conditions
Timeframe: Baseline
Number of Infants With Abnormal Physical Finding
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Heart Rate of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Respiratory Rate of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Blood Pressure of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Weight of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Height of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Temperature of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Head Circumference of the Infant
Timeframe: Baseline, Week 12, Week 24, Week 36, Week 48, and Week 72
Number of Participants With Normal Overall Assessment Measured Using Denver II Developmental Screening Scores
Timeframe: Week 12, Week 24, Week 36, Week 48, and Week 72
Number of Infants With IgM and IgG Antibodies to Laronidase Present at Any Time Point
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 72
Time to Development of IgM and IgG Antibodies to Laronidase
Timeframe: up to Week 72
Amount of IgG and IgM Antibody Titers to Laronidase
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 72