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

PHASE4CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 10, 2023

Primary Completion Date

October 25, 2024

Study Completion Date

October 25, 2024

Conditions
Fabry's Disease
Interventions
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

Trial Locations (5)

10021

Metropolitan Hospital Center Site Number : 1004, New York

22030

Lysosomal and Rare Disorders Research and Treatment Center, Inc Site Number : 1002, Fairfax

49525

Infusion Associates Site Number : 1001, Grand Rapids

90404

UCLA Medical Center Site Number : 1003, Santa Monica

30322-1007

Emory University School of Medicine Site Number : 1005, Atlanta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY