NCT01304277

This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.

A Phase II Comparability Study Between Replagal® Produced From Agalsidase Alfa Manufactured by 2 Different Processes in Adult Male Patients With Fabry Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Shire · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.

Detailed description

In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure. An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free media replaced the previous roller bottle (RB) process. This study is designed to provide PD/PK and safety data. The assessment schedule is designed to capture the PK profile of drug uptake in the blood as well the pharmacologic effect which manifests over the course of weeks. Each patient will serve as his own control.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
BIOLOGICAL	agalsidase alfa

Timeline

• Start date: 2011-11-17
• Primary completion: 2012-12-28
• Completion: 2012-12-28
• First posted: 2011-02-25
• Last updated: 2021-07-19
• Results posted: 2014-04-25

Locations

5 sites across 1 country: Canada