agalsidase alfa

BIOLOGICAL7 trials

Sponsors

Shire, Amicus Therapeutics, Sanofi

Conditions

Fabry Disease

Phase 2

Replagal Enzyme Replacement Therapy for Children With Fabry Disease

CompletedNCT00084084

ShireFabry Disease

Start: 2004-06-10End: 2011-06-15Updated: 2021-07-30

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

CompletedNCT01196871

Amicus TherapeuticsFabry Disease

Start: 2011-02-02End: 2012-10-09Updated: 2018-12-19

This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.

CompletedNCT01304277

ShireFabry Disease

Start: 2011-11-17End: 2012-12-28Updated: 2021-07-19

Phase 3

A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

CompletedNCT01298141

ShireFabry Disease

Start: 2011-08-10End: 2017-09-25Updated: 2021-06-08

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

Active, not recruitingNCT05280548

SanofiFabry Disease

Start: 2022-05-03End: 2027-12-06Updated: 2026-03-10

Phase 4

To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease

WithdrawnNCT04143958

SanofiFabry Disease

Start: 2020-09-30End: 2023-11-30Updated: 2023-04-07

Unknown Phase

Treatment Protocol of Replagal for Patients With Fabry Disease

ShireFabry Disease

Updated: 2021-05-24

Related Papers

The Safety of Agalsidase Alfa Enzyme Replacement Therapy in Canadian Patients with Fabry Disease Following Implementation of a Bioreactor Process

Drugs in R&D2021-09-204 citations

Oral Migalastat HCl Leads to Greater Systemic Exposure and Tissue Levels of Active α-Galactosidase A in Fabry Patients when Co-Administered with Infused Agalsidase

PLoS ONE2015-08-0762 citations

Effect and Tolerability of Agalsidase Alfa in Patients with Fabry Disease Who Were Treatment Naïve or Formerly Treated with Agalsidase Beta or Agalsidase Alfa.

2015-03-3116 citations

Agalsidase alfa in pediatric patients with Fabry disease: a 6.5-year open-label follow-up study.

2014-11-2626 citations