Agalsidase beta

BIOLOGICAL9 trials

Sponsors

Genzyme, a Sanofi Company, Amicus Therapeutics, Protalix, Mackay Memorial Hospital

Conditions

Alpha Galactosidase A DeficiencyFabry Disease

Phase 2

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

Phase 3

A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms

CompletedNCT00701415

Genzyme, a Sanofi CompanyFabry Disease

Start: 2008-09-30End: 2015-06-30Updated: 2016-06-29

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

CompletedNCT02795676

ProtalixFabry Disease

Start: 2016-06-30End: 2022-07-31Updated: 2023-09-13

Phase 4

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

CompletedNCT00081497

Genzyme, a Sanofi CompanyFabry Disease

Start: 2004-01-31End: 2005-09-30Updated: 2015-04-02

A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease

CompletedNCT00140621

Genzyme, a Sanofi CompanyFabry Disease

Start: 2005-07-31End: 2012-08-31Updated: 2015-05-12

Study of the Effects of Fabrazyme Treatment on Lactation and Infants

TerminatedNCT00230607

Genzyme, a Sanofi CompanyAlpha Galactosidase A Deficiency, Fabry Disease

Start: 2006-05-28End: 2024-02-09Updated: 2024-04-10

A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta

CompletedNCT01650779

Genzyme, a Sanofi CompanyFabry Disease

Start: 2012-04-30End: 2013-03-31Updated: 2014-07-10

China Post-marketing Surveillance (PMS) Study of Fabrazyme®

CompletedNCT05054387

Genzyme, a Sanofi CompanyFabry Disease

Start: 2021-10-13End: 2023-03-09Updated: 2025-09-11

Unknown Phase

Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease

RecruitingNCT05698901

Mackay Memorial HospitalFabry Disease

Start: 2023-09-19End: 2027-09-30Target: 150Updated: 2023-11-18

Related Papers

A phase 4, open-label, multicenter study of the safety and efficacy of agalsidase beta in Chinese patients with Fabry disease

Orphanet Journal of Rare Diseases2025-08-04

Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials.

2025-01-23

Head-to-head trial of pegunigalsidase alfa versus agalsidase beta in patients with Fabry disease and deteriorating renal function: results from the 2-year randomised phase III BALANCE study.

2024-05-2134 citations

#636 A phase 4, open label, multicenter prospective study of the safety and efficacy of agalsidase beta in Chinese patients with Fabry disease

Nephrology Dialysis Transplantation2024-05-011 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

Characterization of Early Disease Status in Treatment-Naive Male Paediatric Patients with Fabry Disease Enrolled in a Randomized Clinical Trial

PLoS ONE2015-05-0848 citations