NCT03019406 - A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 12, 2017

Primary Completion Date

September 30, 2019

Study Completion Date

December 30, 2026

Conditions

Glycogen Storage Disease Type II-Pompe's Disease

Interventions

DRUG

Avalglucosidase alfa (GZ402666)

"Pharmaceutical form: powder for concentrate for solution for infusion,~Route of administration: IV"

DRUG

Alglucosidase alfa (GZ419829)

"Pharmaceutical form: powder for concentrate for solution for infusion,~Route of administration: IV"

Trial Locations (12)

Regional Medical Genetics Center of New York Site Number : 8400002, Valhalla

Investigational Site Number : 1580001, Hsinchu

Investigational Site Number : 2500001, Tours

Investigational Site Number : 2500004, Nantes

Investigational Site Number : 2500003, Paris

Investigational Site Number : 2500002, Paris

Seattle Childrens Hospital and Regional Medical Center Site Number : 8400005, Seattle

Duke University Medical Center Site Number : 8400001, Durham

Investigational Site Number : 3920001, Fuchu-shi

Investigational Site Number : 3920002, Fuchu-shi

Investigational Site Number : 8260001, London

Investigational Site Number : 8260002, Manchester

All Listed Sponsors

lead

Genzyme, a Sanofi Company

INDUSTRY