Replagal (agalsidase alfa) / Samaritan Pharma, Takeda  >>  Phase 3
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11 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Replagal (agalsidase alfa) / Samaritan Pharma, Takeda
2021-002320-20: A study to evaluate the effect of venglustat tablets on left ventricular mass index in male and female adult participants with Fabry disease Un estudio para evaluar el efecto de comprimidos de venglustat sobre el índice de masa ventricular izquierda en pacientes hombres y mujeres adultos con enfermedad de Fabry.

Ongoing
3
110
Europe
Venglustat, SAR402671, GZ402671 or GZ/SAR402671, Tablet, Concentrate for solution for infusion, Powder for concentrate for solution for infusion, Capsule, hard, Replagal, Fabrazyme, Galafold
sanofi-aventis recherche et développement, sanofi-aventis recherche et développement
Fabry’s disease Enfermedad de Fabry, Fabry’s disease Enfermedad de Fabry, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
NCT00864851 / 2007-005543-22: Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

Completed
3
44
Europe, US, RoW
Replagal, algasidase alfa
Shire
Fabry Disease
06/12
07/12
NCT01124643 / 2009-015985-75: Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease

Completed
3
35
Europe, US, RoW
Replagal, algalsidase alfa, alpha-Galactosidase, DRX005B
Shire
Fabry Disease
07/13
07/13
NCT01218659 / 2010-022636-37: Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease

Completed
3
68
Japan, US, Europe, RoW
migalastat hydrochloride, AT1001, Migalastat, Galafold, agalsidase, agalsidase beta; Fabrazyme, agalsidase alfa; Replagal
Amicus Therapeutics
Fabry Disease
05/14
05/15
NCT01298141: A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

Completed
3
171
Canada
agalsidase alfa, Replagal
Shire
Fabry Disease
09/17
09/17
BRIDGE, NCT03018730 / 2016-001318-11: Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)

Hourglass May 2019 - Dec 2019 : From BRIDGE study
Checkmark For the treatment of Fabry disease
Feb 2019 - Feb 2019: For the treatment of Fabry disease
Checkmark Data from PB-102-F30 study at 1st Canadian Symposium on Lysosomal Diseases 2018 [screenshot]
Oct 2018 - Oct 2018: Data from PB-102-F30 study at 1st Canadian Symposium on Lysosomal Diseases 2018 [screenshot]
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Completed
3
22
Europe, Canada, RoW
PRX-102 (pegunigalsidase alfa), pegunigalsidase alfa, Recombinant human alpha galactosidase-A
Protalix, Chiesi Farmaceutici S.p.A.
Fabry Disease
12/19
01/20
BRIGHT, NCT03180840 / 2017-001528-23: Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks

Checkmark Interim data from BRIGHT trial
Oct 2019 - Oct 2019: Interim data from BRIGHT trial
Checkmark From BRIGHT trial
Feb 2019 - Feb 2019: From BRIGHT trial
Completed
3
30
Europe, US, RoW
Pegunigalsidase alfa, PRX-102, Recombinant human alpha galactosidase-A
Protalix, Chiesi Farmaceutici S.p.A.
Fabry Disease
08/20
08/20
NCT04840667 / 2018-004689-32: A Study of Replagal in Treatment-naïve Adults With Fabry Disease

Terminated
3
17
Europe, Canada
REPLAGAL, SHP675
Shire
Fabry Disease
12/22
12/22
NCT04974749: A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease

Completed
3
20
RoW
REPLAGAL, Agalsidase Alfa, TAK-675
Takeda
Fabry Disease
01/24
01/24
2022-004246-35: A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease

Not yet recruiting
3
20
RoW
Replagal, TAK-675, Concentrate for solution for injection/infusion, Replagal
Takeda Development Center Americas, Inc, Takeda Development Center Americas, Inc
Fabry Disease, Fabry Disease, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
CARAT, NCT05280548 / 2021-002320-20: A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

Recruiting
3
90
Europe, Canada, Japan, US, RoW
Venglustat (GZ402671), Agalsidase alfa, Replagal®, Agalsidase beta (GZ419828), Fabrazyme®, Migalastat, Galafold®
Sanofi, sanofi-aventis recherche et développement
Fabry Disease
12/25
07/27

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