Clinical Trial: Extension Study of Long-term Safety and Efficacy of Myozyme in Patients With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored Enzyme Replacement Therapy (ERT) Studies

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) in Patients With Pompe Disease (

Brief Summary: This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in patients with infantile-onset Pompe disease who were previously treated with rhGAA derived from the Synpac cell line

Detailed Summary:
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome: The objective of this extension study was to monitor the long-term safety and efficacy [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: September 30, 2008
Date Started: April 2003
Date Completion:
Last Updated: February 4, 2014
Last Verified: February 2014