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

Korábbi kezelés

• Contraindication to Fabrazyme or any of the premedications or rescue medications (diphenhydramine, loratadine, cetirizine, fexofenadine, acetaminophen, montelukast, dexamethasone).

Más betegség

• History of significant allergic disease or hypersensitivity to Fabrazyme or other medicinal products.
• Any other medical condition considered to make the increased infusion rate not tolerable at the Investigator's discretion.
  • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Egyéb

• Female participants who are pregnant or breastfeeding.

• \- Participants with confirmed diagnosis of FD who are ≥2 and ≤65 years of age at the time of signing the informed consent form (ICF) or assent, if applicable.
• Cohort 1: female participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
• Cohort 2: non-classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
• Cohort 3: classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
• Cohort 4: participants with body weight \<30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
  • Women of childbearing potential must use a highly effective method of contraception through the study.