Sanofi: Fabry Disease trials

The registry lists 23 Fabry Disease studies with Sanofi as lead sponsor. 1 are open to participants now and 12 have results posted.

Phase 1 1Phase 2 5Phase 3 4Phase 4 9No phase 4(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Fabry Disease Registry & Pregnancy Sub-registryRecruitingNCT00196742
• A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of FabrazymeCompletedNCT06019728Phase 4Results posted
• Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry DiseaseCompletedNCT02489344Phase 2Results posted
• Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry DiseaseCompletedNCT02228460Phase 2Results posted
• A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase BetaCompletedNCT01650779Phase 4Results posted
• Severe Renal Disease Study in Fabry Patients Treated With FabrazymeTerminatedNCT00837824Phase 2Results posted
• A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe SymptomsCompletedNCT00701415Phase 3Results posted
• Study of the Effects of Fabrazyme Treatment on Lactation and InfantsTerminatedNCT00230607Phase 4Results posted
• A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry DiseaseCompletedNCT00196716Phase 2Results posted
• A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry DiseaseCompletedNCT00140621Phase 4Results posted
• A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry DiseaseCompletedNCT00081497Phase 4Results posted
• A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry DiseaseCompletedNCT00074984Phase 4Results posted
• A Study of Fabrazyme in Pediatric Patients With Fabry DiseaseCompletedNCT00074958Phase 2Results posted
• Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in TaiwanCompletedNCT06052800
• Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)CompletedNCT05671770
• A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry DiseaseActive, not recruitingNCT05280548Phase 3
• A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry DiseaseActive, not recruitingNCT05206773Phase 3
• China Post-marketing Surveillance (PMS) Study of Fabrazyme®CompletedNCT05054387Phase 4
• 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 DiseaseWithdrawnNCT04143958Phase 4
• A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry DiseaseTerminatedNCT01839526Phase 1
• A Study in Patients With Fabry Disease Who Are on Chronic Hemodialysis Therapy for Treatment of End-stage Renal Insufficiency.WithdrawnNCT00312767Phase 4
• A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.CompletedNCT00233870
• A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry DiseaseCompletedNCT00074971Phase 3