Sanofi: Mucopolysaccharidosis I trials

The registry lists 11 Mucopolysaccharidosis I studies with Sanofi as lead sponsor. 0 are open to participants now and 7 have results posted.

Phase 1 1Phase 2 2Phase 3 3Phase 4 4No phase 2(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.

• Clinical Study of Aldurazyme in Patients With Mucopolysaccharidosis (MPS) ICompletedNCT00912925Phase 3Results posted
• Immune Tolerance Study With Aldurazyme® (Laronidase)CompletedNCT00741338Phase 1/2Results posted
• A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed InfantsTerminatedNCT00418821Phase 4Results posted
• Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) DiseaseCompletedNCT00258011Phase 3Results posted
• Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) PatientsCompletedNCT00146770Phase 3Results posted
• A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years OldCompletedNCT00146757Phase 2Results posted
• A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) DiseaseCompletedNCT00144781Phase 4Results posted
• China Post-marketing Surveillance (PMS) Study of Aldurazyme®CompletedNCT05134571Phase 4
• A Study to Assess the Safety of Myozyme® and of Aldurazyme® in Male and Female Participants of Any Age Group With Pompe Disease or With Mucopolysaccharidosis Type I (MPS I) in a Home-care SettingCompletedNCT05073783
• Mucopolysaccharidosis I (MPS I) RegistryCompletedNCT00144794
• A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated PatientsCompletedNCT00144768Phase 4