NCT01298141

A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal® (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients with Fabry disease.

Detailed description

This study will evaluate the safety of agalsidase alfa in patients with Fabry disease. Patients diagnosed with Fabry disease who meet current Canadian guidelines for enzyme replacement therapy will be eligible to enroll in the study and will receive agalsidase alfa at a dose of 0.2 mg/kg body weight administered by an IV infusion over 40 minutes every week or every other week, based on previous treatment. Shire has implemented a change to the drug substance manufacturing process. Safety data will be collected in patients receiving product manufactured with this process. There are no changes to the drug product formulation, manufacturing site, manufacturing process, and container closure.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
BIOLOGICAL	agalsidase alfa	Cohort 1: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes every other week (EOW) Cohort 2: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes weekly

Timeline

• Start date: 2011-08-10
• Primary completion: 2017-09-25
• Completion: 2017-09-25
• First posted: 2011-02-17
• Last updated: 2021-06-08
• Results posted: 2019-02-15

Locations

12 sites across 1 country: Canada