Registry for tracking Fabry disease and pregnancy outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Fabry Disease Registry is an international observational program that monitors clinical outcomes for patients diagnosed with Fabry disease, regardless of their treatment status. It aims to enhance understanding of the disease's variability and progression, assist in developing monitoring recommendations, and evaluate the long-term safety and effectiveness of Fabrazyme®. The Pregnancy Sub-registry specifically focuses on pregnant women with Fabry disease, collecting data to better understand the implications of pregnancy in this population. Participation involves routine clinical assessments as determined by the treating physician.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Fabry Registry: All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.
* Fabry Pregnancy Sub-registry:

  * Eligible women must:

    * be enrolled in the Fabry Registry.
    * be pregnant, or have been pregnant with appropriate medical documentation available.
    * provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.

Exclusion Criteria Fabry Registry: There are no exclusion criteria. Fabry Pregnancy Sub-registry: There are no exclusion criteria.

Where it's running

• University Of Alabama Birmingham- Nephrology- Site Number : 840073
  Birmingham, Alabama, United States Recruiting
• Phoenix Children's Hospital- Site Number : 840003
  Phoenix, Arizona, United States Recruiting
• University of Arizona- Site Number : 840015
  Tucson, Arizona, United States Recruiting
• Arkansas Children's Hospital- Site Number : 840109
  Little Rock, Arkansas, United States Recruiting
• University of Arkansas for Medical Sciences- Site Number : 840113
  Little Rock, Arkansas, United States Recruiting
• Southern California Permanente Medical Group- Site Number : 840108
  Los Angeles, California, United States Recruiting

+234 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.