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Early introduction of alglucosidase alfa from a 4000 L bioreactor in the Netherlands
2008-008293-31Phase 4Active
- Sponsor
- Erasmus MC Sophia Children's Hospital
- Start
- Dec 2008
- Modality
- Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 4, open-label, single-arm trial of alglucosidase alfa in Pompe disease, sponsored by Erasmus MC Sophia Children's Hospital. Primary endpoints: Safety of alglucosidase alfa manufactured in a 4000 L bioreactor and Pharmacokinetics of alglucosidase alfa produced in a 4000 L bioreactor. Started Dec 2008; status: active.
02
Drugs
alglucosidase alfa
03
Conditions
Pompe disease
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