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drugset / Trial / NCT06019728

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

NCT06019728 ↗

Phase 4 Completed 8 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-11-10
Primary completion
2024-10-25
Completion
2024-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject agalsidase beta Protein / enzyme biologic 1 mg/kg Intravenous
Background Acetaminophen Small molecule — Oral
Background Cetirizine Other / unclassified — Oral
Background Dexamethasone Small molecule — Oral
Background Diphenhydramine Unknown — Oral
Background Fexofenadine Unknown — Oral
Background Loratadine Small molecule — Oral
Background Montelukast Other / unclassified — Oral

Indications

Fabry disease