18 completed, 1 active not recruiting, 1 no longer available, 1 recruiting. 7 Phase 2, 7 Phase 3, 5 Phase 4, 2 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 7 | Completed 7 |
| Phase 3 | 7 | Completed 5, Active not recruiting 1, Terminated 1 |
| Phase 4 | 5 | Completed 2, Recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Completed 1 |
Follow agalsidase alfa: new trials by email Literature Review of agalsidase alfa trials Research Report on agalsidase alfa
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Replagal in Children and Adults With Fabry Disease in India Replagal - Fabry Disease | Phase 4 | Recruiting | Shire | 5 | 2022-11-01 | 2026-09-03 |
| A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease Venglustat (GZ402671), Agalsidase alfa, Agalsidase beta (GZ419828) - Fabry Disease | Phase 3 | Active not recruiting | Sanofi | 104 | 2022-05-03 | 2026-06-24 |
| A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry Disease REPLAGAL - Fabry Disease | Phase 3 | Completed | Takeda | 20 | 2022-05-01 | 2024-10-08 |
| A Study of Replagal in Treatment-naïve Adults With Fabry Disease REPLAGAL - Fabry Disease | Phase 3 | Terminated | Shire | 17 | 2021-12-28 | 2024-06-17 |
| 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in Male Patients With Classic Fabry Disease agalsidase beta (GZ419828), agalsidase alfa - Fabry Disease | Phase 4 | Withdrawn | Sanofi | 2020-09-01 | 2023-04-07 | |
| Follow-up of Myocardial T1 Relaxation Time in Patients With Anderson Fabry Disease Enzyme replacement therapy (Agalsidase alpha (Replagal®)), Magnetic Resonance Imaging - Anderson-Fabry Disease | Not applicable | Completed | University Hospital, Rouen | 26 | 2017-03-25 | 2026-04-17 |
| Fabry: Renal Function During Long-term ERT by 51Cr-EDTA Clearance Enzyme replacement therapy - Fabry Disease | Completed | Ulla Feldt-Rasmussen | 52 | 2015-04-01 | 2018-10-16 | |
| A Study to Assess the Safety and Tolerability of Lucerastat in Subjects With Fabry Disease Lucerastat, Enzyme replacement therapy (ERT) - Fabry Disease | Phase 1 | Completed | Idorsia Pharmaceuticals Ltd. | 14 | 2015-02-01 | 2018-07-10 |
| This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes. agalsidase alfa - Fabry Disease | Phase 2 | Completed | Shire | 17 | 2011-11-17 | 2021-07-19 |
| Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease migalastat hydrochloride, agalsidase - Fabry Disease | Phase 3 | Completed | Amicus Therapeutics | 68 | 2011-09-08 | 2018-11-01 |
| A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease agalsidase alfa - Fabry Disease | Phase 3 | Completed | Shire | 171 | 2011-08-10 | 2021-06-08 |
| Safety Study of Replagal® Therapy in Children With Fabry Disease Replagal (agalsidase alfa) - Fabry Disease | Phase 2 | Completed | Shire | 15 | 2011-05-12 | 2021-06-09 |
| Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease Migalastat HCl, Agalsidase Beta, Agalsidase Alfa - Fabry Disease | Phase 2 | Completed | Amicus Therapeutics | 20 | 2011-02-02 | 2018-12-19 |
| Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease Replagal - Fabry Disease | Phase 3 | Completed | Shire | 35 | 2010-04-13 | 2021-06-08 |
| Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease Replagal - Fabry Disease | Phase 3 | Completed | Shire | 44 | 2008-12-29 | 2021-06-09 |
| Evaluation of Efficacy and Safety of Agalsidase Beta in Heterozygous Females for Fabry Disease recombinant alpha-galactosidase A - Fabry Disease | Phase 4 | Unknown | Assistance Publique - Hôpitaux de Paris | 34 | 2005-06-01 | 2007-06-18 |
| Replagal Enzyme Replacement Therapy for Adults With Fabry Disease Replagal (Agalsidase Alfa), Replagal - Fabry Disease | Phase 4 | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 25 | 2004-11-01 | 2008-03-04 |
| Replagal Enzyme Replacement Therapy for Children With Fabry Disease Agalsidase alfa - Fabry Disease | Phase 2 | Completed | Shire | 17 | 2004-06-10 | 2021-07-30 |
| Alternative Dosing and Regimen of Replagal to Treat Fabry Disease Replagal - Fabry Disease | Phase 2 | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 25 | 2004-01-01 | 2008-03-04 |
| An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease Replagal agalsidase alfa, Replagal - Fabry Disease | Phase 1 | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 3 | 2003-10-01 | 2011-08-17 |
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Fabry Disease (24) · Stroke (5) · Hypohidrosis (2) · Peripheral Nervous System Diseases (2) · Cardiomyopathies (1) · Kidney Diseases (1) · Pain (1) · Renal Insufficiency (1)
Shire (9) · National Institute of Neurological Disorders and Stroke (NINDS) (4) · Amicus Therapeutics (2) · Sanofi (2) · Assistance Publique - Hôpitaux de Paris (1) · Baylor Research Institute (1) · Copenhagen University Hospital, Rigshospitalet (1) · Idorsia Pharmaceuticals Ltd. (1) · Takeda (1) · Ulla Feldt-Rasmussen (1) · University Hospital, Rouen (1)
United States (13) · Canada (6) · Australia (4) · Denmark (4) · France (4) · Poland (4) · United Kingdom (4) · Czechia (3) · Finland (3) · Germany (3) · Austria (2) · Belgium (2) · China (2) · Greece (2) · Italy (2)
Ulla Feldt-Rasmussen, MD, DMSc (1) · Ulla V Feldt-Rasmussen, MD, DMSc (1)
PMID 20730727, PMID 25425121, PMID 26185417, PMID 26252393, PMID 27307708, PMID 27657681, PMID 27834756, PMID 28088251, PMID 31889231, PMID 31934472, PMID 32994552, PMID 33012654, PMID 34542871, PMID 39988522
2009 (1), 2018 (1), 2019 (1), 2023 (1)