Replagal

DRUG10 trials

Sponsors

Baylor Research Institute, National Institute of Neurological Disorders and Stroke (NINDS), Shire, Takeda

Conditions

Fabry Disease

Phase 1

An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease

CompletedNCT00357786

National Institute of Neurological Disorders and Stroke (NINDS)Fabry Disease

Start: 2003-10-31Target: 3Updated: 2011-08-17

Phase 2

Dosing Study of Replagal in Patients With Fabry Disease

CompletedNCT00068107

Baylor Research InstituteFabry Disease

Start: 2003-09-30End: 2013-12-31Updated: 2015-03-31

An Open-Label Clinical Trial of Replagal Enzyme Therapy in Children Ages 7-17 Years With Fabry Disease

CompletedNCT00071877

National Institute of Neurological Disorders and Stroke (NINDS)Fabry Disease

Start: 2003-10-31End: 2005-06-30Target: 25Updated: 2008-03-04

Alternative Dosing and Regimen of Replagal to Treat Fabry Disease

CompletedNCT00075244

National Institute of Neurological Disorders and Stroke (NINDS)Fabry Disease

Start: 2004-01-31End: 2005-11-30Target: 25Updated: 2008-03-04

Phase 3

Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

CompletedNCT00864851

ShireFabry Disease

Start: 2008-12-29End: 2012-07-05Updated: 2021-06-09

Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease

CompletedNCT01124643

ShireFabry Disease

Start: 2010-04-13End: 2013-07-08Updated: 2021-06-08

A Study of Replagal in Treatment-naïve Adults With Fabry Disease

TerminatedNCT04840667

ShireFabry Disease

Start: 2021-12-28End: 2022-12-16Updated: 2024-06-17

A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease

CompletedNCT04974749

TakedaFabry Disease

Start: 2022-05-01End: 2024-01-03Updated: 2024-10-08

Phase 4

Replagal Enzyme Replacement Therapy for Adults With Fabry Disease

CompletedNCT00097890

National Institute of Neurological Disorders and Stroke (NINDS)Fabry Disease

Start: 2004-11-30End: 2005-12-31Target: 25Updated: 2008-03-04

A Study of Replagal in Children and Adults With Fabry Disease in India

RecruitingNCT05067868

ShireFabry Disease

Start: 2022-11-01End: 2027-10-31Target: 5Updated: 2026-09-03

Related Papers

Evaluation of the efficacy and safety of three dosing regimens of agalsidase alfa enzyme replacement therapy in adults with Fabry disease.

2015-07-0820 citations