Clinical Trial: Home Therapy With Replagal in Fabry Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non Interventional Study of Replagal® Home Therapy in Patients With Fabry Disease

Brief Summary: The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Morbus Fabry disease receiving their Enzyme Replacement Therapy with Replagal (Agalsidase alfa) at home compared to receiving the infusions at the clinic or at doctor's practice.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Patient satisfaction estimated on a 10-ary Likert scale [ Time Frame: comparison of baseline to 12 months value ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number (per infusion) and severity of infusion-related side effects [ Time Frame: baseline compared to 12 months ]

Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: May 16, 2011
Date Started: May 2011
Date Completion: May 2020
Last Updated: February 1, 2017
Last Verified: February 2017