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Clinical Trial Summary

The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe Mucopolysaccharidosis I (MPS I) participants.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00741338
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2008
Completion date September 2012

See also
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Active, not recruiting NCT04453085 - An Extension Study of JR-171-101 Study in Patients With MPS I Phase 1/Phase 2
Completed NCT05134571 - China Post-marketing Surveillance (PMS) Study of Aldurazyme® Phase 4
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Completed NCT00146770 - Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients Phase 3
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Completed NCT00176891 - Stem Cell Transplant w/Laronidase for Hurler Phase 2
Active, not recruiting NCT03153319 - Study to Evaluate the Safety and Efficacy of Adalimumab in MPS I, II, and VI Phase 1/Phase 2
Completed NCT00852358 - A Study of Intrathecal Enzyme Therapy for Cognitive Decline in MPS I N/A
Enrolling by invitation NCT06103487 - Long Term Follow-Up for RGX-111