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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-007003-33-IT |
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Date of registration:
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27/12/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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16/09/2010 |
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Target sample size:
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10 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007003-33 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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mucocopolysaccharidoses I
MedDRA version: 9.1
Level: LLT
Classification code 10056886
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Intervention(s)
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Trade Name: ALDURAZYME*INFUS 1FL 5ML 500U
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Laronidase
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Main Objective: 1. To determine whether Aldurazyme affects lactation in women with MPS I. 2. To determine whether a-L-iduronidase is present in the breast milk of mothers with MPS I who are being treated with Aldurazyme. 3. To determine whether Aldurazyme affects the growth, development, and immunologic response of breastfed infants born to mothers with MPS I who are being treated with Aldurazyme.
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Primary end point(s): The analyses of the data from this study are designed to address the following questions: • Does Aldurazyme affect lactation in women with MPS I? • Is a-L-iduronidase present in the breast milk of treated mothers? • Does Aldurazyme have any effects on the growth, development, and immunologic response of infants born to mothers receiving Aldurazyme? Effects of Aldurazyme on lactation in mothers will be assessed in terms of the proportion of lactating women with serum IgG antibodies to laronidase, and the levels of IgG antibody titers to laronidase, the proportion of women choosing to breastfeed and who are successful at breastfeeding, the proportion of women whose breast milk contains a-L-iduronidase, the levels of a a-L-iduronidase in the breast milk of lactating MPS I mothers, and medical history and physical examination findings. Effects of Aldurazyme on infants will be assessed in terms of the proportion of infants attempting to and successfully breastfeeding, the proportion of infants with IgM and IgG antibodies present at any time point during the 12 to 18 month study period, the levels of IgG and IgM antibody titers to laronidase, medical history and physical and developmental examination findings (including growth), and the time to development of IgM and IgG antibodies.
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Secondary Objective: There are no secondary objectives
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Secondary ID(s)
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ALID01803
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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