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Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease

NCT05843916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-18

Study results available
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Summary

BIO-AGA-Fase III-001 is a Phase III, prospective, multicenter, open-label, single-group, baseline-controlled, switch over clinical trial to evaluate the efficacy and safety of AGA BETA BS in patients with FD already treated and previously stabilized with Fabrazyme®.

Conditions

Interventions

DRUG

Recombinant human alpha galactosidase A (agalsidase beta)

All participants will receive 2 doses of Fabrazyme® with approximately 14 days between them. The dose will be 1 mg/kg of body mass every 2 weeks

DRUG

Recombinant human alpha-galactosidase A (agalsidase beta)

All participants will receive AGA BETA BS for 54 weeks. The dose will be 1 mg/kg of body mass every 2 weeks

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • IQVIA Solutions

    collaborator UNKNOWN

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • Bio Sidus SA

    lead INDUSTRY

Principal Investigators

  • Alberto A Fernández, MD · Instituto de Investigaciones Clínicas Quilmes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2024-09-19
Completion
2025-03-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

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 NCT05843916 on ClinicalTrials.gov