Study of the Effects of Fabrazyme Treatment on Lactation and Infants
Brief description of study
The study will last for up to 2 years (24 months). Full participation for both mother and infant is 24 months, full participation of mother and development of infant is 24 months, while full participation of mother and no infant participation is 6 months
Detailed description of study
NOTE: Estimated Enrollment: 10 mothers and up to 10 infants
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Fabry Disease, Alpha Galactosidase A Deficiency
Gender: Male or Female
Mothers must meet the following criteria to be enrolled in this study:
- provide signed written informed consent to participate in this study,
- be enrolled in the Fabry Registry and receiving Fabrazyme while lactating,
- agree to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
- agree to adhere to the schedule of evaluations for this study.
Infants must meet the following criteria to be enrolled in this study:
- have the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
- be born to a mother who is receiving Fabrazyme during lactation,
- be receiving breast milk from the mother, and
- have the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.
- 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.
Find a site
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting