8 completed, 2 withdrawn, 1 recruiting, 1 terminated. 13 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 13 | Completed 8, Withdrawn 2, Recruiting 1, Terminated 1, Unknown 1 |
Follow Fabry Disease: new trials by email Literature Review of Fabry Disease trials Research Report on Fabry Disease
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 |
| 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 |
| 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in Male Patients With Classic Fabry Disease agalsidase beta (GZ419828), agalsidase alfa - Fabry Disease | Phase 4 | Withdrawn | Sanofi | 2020-09-01 | 2023-04-07 | |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 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 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 Fabrazyme (agalsidase beta) - Fabry Disease | Phase 4 | Withdrawn | Genzyme, a Sanofi Company | 2006-04-01 | 2014-02-05 | |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 |
| 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 |
| A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease agalsidase beta - Fabry Disease | Phase 4 | Completed | Genzyme, a Sanofi Company | 67 | 2004-01-01 | 2015-04-02 |
| Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients. Enzyme replacement - Fabry Disease | Phase 4 | Completed | Copenhagen University Hospital, Rigshospitalet | 39 | 2001-09-01 | 2014-10-28 |
| A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease Fabrazyme (agalsidase beta), Placebo - Fabry Disease | Phase 4 | Completed | Genzyme, a Sanofi Company | 82 | 2001-02-01 | 2013-12-27 |
Cardiomyopathies (1) · Lysosomal Storage Diseases (1) · Stroke (1)
Brain Diseases (13) · Brain Diseases, Metabolic (13) · Brain Diseases, Metabolic, Inborn (13) · Cardiovascular Diseases (13) · Central Nervous System Diseases (13) · Cerebral Small Vessel Diseases (13) · Cerebrovascular Disorders (13) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Genetic Diseases, Inborn (13) · Genetic Diseases, X-Linked (13) · Lipid Metabolism Disorders (13) · Lipid Metabolism, Inborn Errors (13) · Lipidoses (13) · Lysosomal Storage Diseases, Nervous System (13) · Metabolic Diseases (13)
agalsidase beta (10) · agalsidase alfa (5) · Acetaminophen (1) · Cetirizine (1) · Dexamethasone (1) · Diphenhydramine (1) · Enzyme Replacement Therapy (1) · Loratadine (1) · fexofenadine (1) · montelukast (1)
Genzyme, a Sanofi Company (7) · Sanofi (2) · Assistance Publique - Hôpitaux de Paris (1) · Copenhagen University Hospital, Rigshospitalet (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1) · Shire (1)
United States (7) · United Kingdom (3) · Canada (2) · Czechia (2) · Hungary (2) · Poland (2) · Austria (1) · China (1) · Denmark (1) · France (1) · India (1) · Japan (1)
Ulla Feldt-Rasmussen, MD, DMSc (1)
2019 (1)