CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
AGALSIDASE BETA (GZ419828) +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06019728
NCT06019728Phase 4Completed
CompareCT.gov

A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion

Sanofi·interventional·Posted Aug 31, 2023·Updated Oct 21, 2025

In Brief

A Phase 4 clinical trial evaluating AGALSIDASE BETA (GZ419828), Acetaminophen, and 6 other interventions for Fabry's Disease. Completed, enrolled 8 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedAug 31, 2023
Enrollment StartNov 10, 2023
Primary CompletionOct 25, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.8 years ago

Interventions

AGALSIDASE BETA (GZ419828)drug

Pharmaceutical form: Lyophilized powder for reconstitution Route of administration: IV infusion

Acetaminophendrug

Tablet or solution; Oral

Diphenhydraminedrug

Tablet or solution; Oral

Dexamethasonedrug

Tablet or solution; Oral

Montelukastdrug

Tablet or chewable tablet or oral granules; Oral

Loratadinedrug

Tablet or chewable tablet; Oral

Cetirizinedrug

Tablet or oral solution; Oral

Fexofenadinedrug

Tablet or oral suspension; Oral