drugset / Trial / NCT00765414

Extension Study of Long-term Safety and Efficacy of Myozyme for a Single Patient With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored ERT Studies.

NCT00765414

Phase 2 Completed 1 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in a single patient with infantile-onset Pompe disease who were previously treated with rhGAA in a Genzyme study.

Timeline

Start
2003-04
Primary completion
2006-04
Completion
2006-08

Drugs

EvaluationDrugModalityDoseRoute
Subject alglucosidase alfa Protein / enzyme biologic 30 mg/kg
Subject alglucosidase alfa Protein / enzyme biologic 40 mg/kg