21 completed, 2 terminated, 2 withdrawn, 1 active not recruiting. 10 Phase 4, 7 Phase 3, 4 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 10 | Completed 7, Withdrawn 2, Terminated 1 |
| Phase 3 | 7 | Completed 5, Active not recruiting 1, Unknown 1 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
Follow agalsidase beta: new trials by email Literature Review of agalsidase beta trials Research Report on agalsidase beta
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 Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme AGALSIDASE BETA (GZ419828), Acetaminophen, Diphenhydramine - Fabry's Disease | Phase 4 | Completed | Sanofi | 8 | 2023-11-10 | 2025-10-21 |
| Biomarkers and Cardiac Imaging Diagnostic Assay for Monitoring Patients With Fabry Disease Agalsidase beta - Fabry Disease | Recruiting | Mackay Memorial Hospital | 150 | 2023-09-19 | 2023-11-18 | |
| Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease Fabagal® (Agalsidase beta), Active comparator (Agalsidase beta) - Fabry Disease | Phase 3 | Unknown | ISU Abxis Co., Ltd. | 24 | 2023-04-14 | 2024-07-29 |
| Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease Recombinant human alpha galactosidase A (agalsidase beta), Recombinant human alpha-galactosidase A (agalsidase beta) - Fabry Disease | Phase 3 | Completed | Bio Sidus SA | 20 | 2022-12-13 | 2026-02-18 |
| 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 |
| PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion Agalsidase beta from Biosidus 1 mg/kg, Fabrazyme (agalsidase beta) 1 mg/kg - Fabry Disease | Phase 1 | Completed | Bio Sidus SA | 24 | 2021-10-23 | 2025-10-15 |
| China Post-marketing Surveillance (PMS) Study of Fabrazyme® Agalsidase beta - Fabry Disease | Phase 4 | Completed | Genzyme, a Sanofi Company | 22 | 2021-10-13 | 2025-09-11 |
| 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 | |
| A Study to Describe the Experience of Both Patients and Their Clinicians in the Treatment of Fabry Disease With Enzyme Replacement Therapy. Enzyme Replacement Therapy (ERT) - Fabry Disease | Completed | Amicus Therapeutics | 82 | 2020-03-01 | 2026-02-05 | |
| Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function PRX-102 (pegunigalsidase alfa), agalsidase beta - Fabry Disease | Phase 3 | Completed | Protalix | 78 | 2016-06-01 | 2023-09-13 |
| 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 |
| A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta Agalsidase beta - Fabry Disease | Phase 4 | Completed | Genzyme, a Sanofi Company | 15 | 2012-04-01 | 2014-07-10 |
| 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 |
| 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 |
| A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms Agalsidase beta - Fabry Disease | Phase 3 | Completed | Genzyme, a Sanofi Company | 31 | 2008-09-01 | 2016-06-29 |
| The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study enalapril and other angiotensin converting enzyme inhibitors; losartan and other angiotensin receptor blockers - Fabry Disease, Proteinuria | Completed | University of Alabama at Birmingham | 36 | 2007-03-01 | 2013-11-19 | |
| Study of the Effects of Fabrazyme Treatment on Lactation and Infants agalsidase beta - Fabry Disease, Alpha Galactosidase A Deficiency | Phase 4 | Terminated | Genzyme, a Sanofi Company | 7 | 2006-05-28 | 2024-04-10 |
| A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency. Fabrazyme (agalsidase beta) - Fabry Disease | Phase 4 | Withdrawn | Genzyme, a Sanofi Company | 2006-04-01 | 2014-02-05 | |
| A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease Agalsidase beta - Fabry Disease | Phase 4 | Completed | Genzyme, a Sanofi Company | 6 | 2005-07-01 | 2015-05-12 |
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Fabry Disease (28) · Proteinuria (2) · Disease Progression (1) · Kidney Diseases (1) · Lysosomal Storage Diseases (1) · Renal Insufficiency, Chronic (1)
Genzyme, a Sanofi Company (13) · Amicus Therapeutics (3) · Sanofi (3) · Bio Sidus SA (2) · Copenhagen University Hospital, Rigshospitalet (1) · ISU Abxis Co., Ltd. (1) · Idorsia Pharmaceuticals Ltd. (1) · Mackay Memorial Hospital (1) · Protalix (1) · Ulla Feldt-Rasmussen (1) · University of Alabama at Birmingham (1)
United States (16) · United Kingdom (9) · Czechia (6) · Poland (6) · Canada (5) · France (5) · Japan (5) · Netherlands (5) · Denmark (4) · Argentina (3) · Austria (3) · Brazil (3) · Hungary (3) · Italy (3) · Norway (3)
Charles Jia-Yin Hou (1) · David G Warnock, MD (1) · Eduardo Pirotzky, MD (1) · Ulla Feldt-Rasmussen, MD, DMSc (1) · Ulla V Feldt-Rasmussen, MD, DMSc (1)
PMID 17179052, PMID 18346516, PMID 23531228, PMID 25795794, PMID 25955246, PMID 26252393, PMID 26490103, PMID 27657681, PMID 27834756, PMID 28088251, PMID 31889231, PMID 31934472, PMID 32994552, PMID 33012654, PMID 33599146, PMID 37488580, PMID 37940383, PMID 39847314, PMID 40760696, PMID 40790487
2019 (1), 2023 (1)