This study is currently not recruiting participants.

Study of the Effects of Fabrazyme Treatment on Lactation and Infants

Study on Lactation and Infant Outcomes

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.

This study investigates the effects of an investigational medication on lactation and infants. It includes mothers who are receiving this medication while breastfeeding.

The purpose of this study is to evaluate how the investigational medication affects both mothers and their infants during lactation. It looks at various health aspects and development of the infants.

  • Who can participate: Mothers in the Fabry Registry receiving the investigational medication while breastfeeding can participate. Infants born to these mothers and receiving breast milk are also eligible.
  • Study details: Participants will follow a schedule of evaluations to monitor health and development. A placebo is not mentioned in this study. It is important for participants to follow the study's assessment schedule.
  • Study timelines: The study will last 24 months for full participation of both mother and infant, and 6 months for mothers without infant participation.
Updated on 10 Apr 2024. Study ID: NCT00230607