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A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

Studying the safety of quicker Fabrazyme infusions for patients.

Recruiting
2-65 years
All
Phase 4

This Phase 4 study looks at the safety of using Fabrazyme with a faster drip (infusion) and less liquid. Fabrazyme is a medicine used to treat Fabry Disease (FD), a genetic condition affecting fats in the body. The study is for people who are 2 to 65 years old and have been using Fabrazyme for at least 3 months without problems. The study will last up to 6 months. Participants will be divided into groups based on their age, weight, and type of FD. Some people, called ERT-naïve, will be new to enzyme replacement therapy (ERT) like Fabrazyme. Women who can have children must use safe birth control during the study. You cannot join if you're pregnant, breastfeeding, allergic to Fabrazyme, or have medical conditions that make a faster infusion unsafe.

  • Study Duration: Up to 6 months
  • Eligibility: Ages 2-65, using Fabrazyme for 3+ months without issues
  • Exclusions: Pregnant/breastfeeding, allergies to study medications
Study details
    Fabry's Disease

NCT06019728

Sanofi

12 October 2024

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