A Study of the Effects of Fabrazyme on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants - NCT00230607-53201 (Clinical Trial 131416)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy131416.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53201 |
| Conditions: |
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Fabry Disease |
| Purpose: |
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The purpose of this study is to observe the potential effects of Fabrazyme treatment on
lactation and on the growth, development, and immunologic response of infants born to
mothers with Fabry disease who are treated with Fabrazyme during lactation.
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| Study summary: |
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NOTE: Estimated Enrollment: 10 mothers and up to 10 infants |
| Criteria: |
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Inclusion Criteria:
- Mother must provide signed written informed consent to participate in this study.
- Mother must be enrolled in the Fabry Registry and receiving Fabrazyme while
lactating.
- Mother must agree to adhere to the Fabry Registry recommended schedule of assessments
for medical history, pregnancy outcome, genotyping, and antibody testing.
- Mother must agree to adhere to the schedule of evaluations for this study.
- Infant must have the signed written informed consent of the parent(s)/legal
guardian(s) to participate in this study.
- Infant must be born to a mother who is receiving Fabrazyme during lactation.
- Infant must be receiving breast milk from the mother.
- Infant must have the agreement of the parent(s)/legal guardian(s) to adhere to the
schedule of evaluations for this study.
Exclusion Criteria:
- The mother and infant will be excluded from this study if the mother has received an
investigational drug within 30 days prior to study enrollment. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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