RECRUITING

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

Official Title

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Quick Facts

Study Start:2020-04-17
Study Completion:2030-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04252066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat
  2. 2. Able and willing to provide informed consent or assent, if applicable.
  3. 3. Able and willing to provide HCP contact information.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Pregnancy Registry Call Center
CONTACT
888-239-0758
galafoldpregnancy@ubc.com

Study Locations (Sites)

Amicus Therapeutics, Inc. Pregnancy Registry
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Amicus Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-17
Study Completion Date2030-02

Study Record Updates

Study Start Date2020-04-17
Study Completion Date2030-02

Terms related to this study

Keywords Provided by Researchers

  • migalastat
  • Fabry Disease
  • Women with Fabry Disease

Additional Relevant MeSH Terms

  • Fabry Disease