NCT06019728CompletedPhase 4
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion
Source: ClinicalTrials.gov · Last updated 21 Oct 2025
Brief summary (registry, in English)
This Phase 4 study will evaluate the safety and tolerability of Fabrazyme at current approved dose with increases in the infusion rate and reduced infusion volume. This study aims to generate data to provide the guidance on how infusion rate can be safely increased and minimize the burden of the life-long treatment with Fabrazyme.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 25 Aug 2023
- Start date
- 10 Nov 2023
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Sanofi
- Diseases
- Fabry disease
- NCT number
- NCT06019728
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 8
- From 10 Nov 2023 to the primary completion date, 25 Oct 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to Fabrazyme or any of the premedications or rescue medications (diphenhydramine, loratadine, cetirizine, fexofenadine, acetaminophen, montelukast, dexamethasone).
Other illness
- 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.
Other
- Female participants who are pregnant or breastfeeding.
Who the study is looking for
- \- 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.
Age in the registry: 2 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University School of Medicine Site Number : 1005 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Lysosomal and Rare Disorders Research and Treatment Center, Inc Site Number : 1002 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Metropolitan Hospital Center Site Number : 1004 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UCLA Medical Center Site Number : 1003 Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.