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Prophylactic immunomodulation before Myozyme in Myozyme-naive CRIM-negative infantile-onset Pompe disease
2015-000584-14Phase 4
- Sponsor
- Sanofi
- Start
- Apr 2015
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
- Countries
- 1
01
Overview
Phase 4, open-label, single-arm trial of alglucosidase alfa, rituximab and methotrexate in Pompe disease, sponsored by Sanofi. Primary endpoint: Change from baseline in number of patients with anti-rhGAA IgG antibody at end of study.
02
Drugs
alglucosidase alfarituximabmethotrexate
03
Conditions
Pompe disease
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