Study of the Effects of Fabrazyme Treatment on Lactation and Infants

  • STATUS
    Recruiting
  • End date
    Nov 26, 2024
  • participants needed
    20
  • sponsor
    Genzyme, a Sanofi Company
Updated on 26 May 2022
agalsidase beta
fabrazyme

Summary

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

Description

NOTE: Estimated Enrollment: 10 mothers and up to 10 infants

Details
Condition Fabry Disease, Alpha Galactosidase A Deficiency
Treatment agalsidase beta
Clinical Study IdentifierNCT00230607
SponsorGenzyme, a Sanofi Company
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
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

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note