A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
Completed · Phase 4 · NCT06019728
Conditions: Fabry's Disease
At a glance
- Research payments reported, 2025
- $69,533
- U.S. investigators named
- 5
- Sites paid
- 5
- Planned or actual enrollment
- 8
About the trial
- Sponsor
- Sanofi
- Tested
- AGALSIDASE BETA (GZ419828) (drug), Acetaminophen (drug), Diphenhydramine (drug), Dexamethasone (drug), Montelukast (drug), Loratadine (drug), Cetirizine (drug), Fexofenadine (drug)
- Dates
- Started 2023-11-10; completion 2024-10-25
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-10-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $69,533 in research payments for this study in 2025 (28 payments).
Products named: Fabrazyme
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Mrinalini Sarkar, MD Nephrology (Kidney) · West Hollywood, CA
- William Wilcox Medical Genetics · Decatur, GA
- Khan J. Nedd, M.D. Internal Medicine · Grand Rapids, MI
- Maryam Banikazemi, MD Ph.D. Medical Genetics (non-physician) · Valhalla, NY
- Ozlem Goker-alpan, M.D. Pediatrics · Fairfax, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Emory University Hospital, GA $35,645
- Metropolitan Hospital Center, NY $12,042
- Ronald Reagan UCLA Medical Center, CA $8,214
- Lysosomal and Rare Disorders Research and Treatment Center Inc $6,950
- Vivo Infusion Grand Rapids $6,682
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.