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

PHASE3CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

August 10, 2011

Primary Completion Date

September 25, 2017

Study Completion Date

September 25, 2017

Conditions
Fabry Disease
Interventions
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"

Trial Locations (12)

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2H7

University of Alberta Hospital, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

R3A 1S1

University of Manitoba, Winnipeg

B3H 1V8

Queen Elizabeth II Health Sciences Centre, Halifax

B3K 6R8

Izaak Walton Killam (IWK) Health Centre, Halifax

K7L 3J6

Kingston General Hospital, Kingston

N6C 2V5

London Health Sciences Centre - Victoria Hospital, London

M5G 1X8

The Hospital for Sick Children, Toronto

M5T 3L9

The Fred A. Litwin Family Centre in Genetic Medicine, Toronto

H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY