Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The total duration will be up to 7 months
Age
2–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\- 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.
You may not be if
Female participants who are pregnant or breastfeeding.
History of significant allergic disease or hypersensitivity to Fabrazyme or other medicinal products.
Contraindication to Fabrazyme or any of the premedications or rescue medications (diphenhydramine, loratadine, cetirizine, fexofenadine, acetaminophen, montelukast, dexamethasone).
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.
Clareo Health | A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
