Trial intelligence / Profile preview

Prophylactic ITI in CRIM-Negative Infantile Pompe Disease

NCT00701129Phase 4Completed

Sponsor
Sanofi
Start
Oct 2009
Primary completion
Mar 2013
Modality
Replacement Enzymes
Countries
1
01

Overview

Phase 4, open-label, single-arm trial of alglucosidase alfa in Pompe disease, sponsored by Sanofi. Primary endpoints: Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at Week 79, Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at Week 79 and 6 more. Started Oct 2009; status: completed.

02

Drugs

alglucosidase alfa
03

Conditions

Pompe disease

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