36
Participants
Start Date
December 18, 2015
Primary Completion Date
March 15, 2021
Study Completion Date
October 19, 2023
placebo (saline)
"Pharmaceutical form: solution administered once every two weeks during the 52 weeks of the primary analysis period for participants randomized to placebo.~Route of administration: intravenous infusion"
Olipudase alfa
"Pharmaceutical form: Powder for concentrate for solution for infusion administered once every two weeks during the 52 weeks of the primary analysis period for participants randomized to olipudase alfa, and during the extension treatment period for all participants.~Route of administration: intravenous infusion"
Investigational Site Number : 788001, Tunis
Investigational Site Number : 100001, Sofia
Investigational Site Number : 036001, Westmead
Investigational Site Number : 056001, Leuven
Montefiore Medical Center Site Number : 840006, The Bronx
Investigational Site Number : 724001, Madrid
Emory University Site Number : 840003, Decatur
Investigational Site Number : 380001, Udine
Investigational Site Number : 792004, Istanbul
Investigational Site Number : 792003, Istanbul
Investigational Site Number : 792001, Izmir
Investigational Site Number : 276001, Mainz
Investigational Site Number : 250001, Paris
Investigational Site Number : 380002, Napoli
UCSF Medical Center Site Number : 840005, San Francisco
Investigational Site Number : 032001, Córdoba
Hospital De Clinicas De Porto Alegre Site Number : 076001, Porto Alegre
Investigational Site Number : 152001, Santiago
Investigational Site Number : 392001, Fukushima
Investigational Site Number : 528001, Amsterdam
Investigational Site Number : 620002, Porto
Investigational Site Number : 792002, Ankara
Investigational Site Number : 826001, London
Investigational Site Number : 826002, Birmingham
Genzyme, a Sanofi Company
INDUSTRY