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

NCT06019728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-10-21

Study results available
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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.

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-10-25
Completion
2024-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019728 on ClinicalTrials.gov