Study of the Effects of Fabrazyme Treatment on Lactation and Infants

Study on Investigational Treatment During Lactation for Fabry Disease

Not Recruiting
All
Phase 4
7 participants needed

Study Overview

The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full participation of mother and no infant participation was 6 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Fabry Disease, Alpha Galactosidase A Deficiency
  • Gender: All

Inclusion Criteria:

Mothers that met the following criteria were enrolled in this study:

  • provided signed written informed consent to participate in this study,
  • be enrolled in the Fabry Registry and received Fabrazyme while lactating,
  • agreed to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
  • agreed to adhere to the schedule of evaluations for this study.

Infants that met the following criteria were enrolled in this study:

  • had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
  • born to a mother who was receiving Fabrazyme during lactation,
  • received breast milk from the mother, and
  • had 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 were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.

Updated on 10 Apr 2024. Study ID: NCT00230607

This study investigates the effects of an investigational treatment on mothers and their infants during lactation. It focuses on the condition known as Fabry disease, which is a genetic disorder that affects the body's ability to break down a specific type of fat, leading to a range of symptoms. The purpose of this study is to understand how the investigational treatment interacts with lactation and the health of both the mother and the infant.

Participants in this study will follow specific procedures, including regular assessments of medical history, pregnancy outcomes, genotyping, and antibody testing. The study will also involve evaluations to monitor the health of the infants who receive breast milk from mothers undergoing the investigational treatment.

  • Who can participate: Eligible participants include mothers from the Fabry Registry who have received the investigational treatment while lactating. Infants who receive breast milk from these mothers can also participate.
  • Study details: Participants will need to adhere to a schedule of assessments, including medical history and antibody testing. Infants will be monitored for health as they receive breast milk from mothers on the investigational treatment.
  • Study Timelines: The study will last 24 months.