NCT06019728

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The total duration will be up to 7 months

Conditions

• Fabry's Disease

Interventions

Type	Name	Description
DRUG	AGALSIDASE BETA (GZ419828)	Pharmaceutical form: Lyophilized powder for reconstitution Route of administration: IV infusion
DRUG	Acetaminophen	Tablet or solution; Oral
DRUG	Diphenhydramine	Tablet or solution; Oral
DRUG	Dexamethasone	Tablet or solution; Oral
DRUG	Montelukast	Tablet or chewable tablet or oral granules; Oral
DRUG	Loratadine	Tablet or chewable tablet; Oral
DRUG	Cetirizine	Tablet or oral solution; Oral
DRUG	Fexofenadine	Tablet or oral suspension; Oral

Timeline

• Start date: 2023-11-10
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2023-08-31
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study