Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

November 2, 2016

Primary Completion Date

March 19, 2020

Study Completion Date

May 31, 2023

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: intravenous

DRUG

Alglucosidase alfa (GZ419829)

Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous

Trial Locations (69)

1070

Investigational Site Number 0560003, Brussels

1083

Investigational Site Number 3480001, Budapest

1090

Investigational Site Number 0400001, Vienna

2100

Investigational Site Number 2080003, København Ø

3000

Investigational Site Number 0560001, Leuven

4066

Investigational Site Number 0360001, Auchenflower

8091

Investigational Site Number 7560002, Zurich

10043

Investigational Site Number 1580001, Taipei

10126

Investigational Site Number 3800003, Torino

10595

Investigational Site Number 8400008, Valhalla

11020

Investigational Site Number 8400026, Great Neck

12808

Investigational Site Number 2030001, Prague

13385

Investigational Site Number 2500006, Marseille

15213

Investigational Site Number 8400025, Pittsburgh

20122

Investigational Site Number 3800002, Milan

22030

Investigational Site Number 8400005, Fairfax

25123

Investigational Site Number 3800006, Brescia

26506

Investigational Site Number 8400024, Morgantown

27710

Investigational Site Number 8400006, Durham

29609

Investigational Site Number 2500011, Brest

30033

Investigational Site Number 8400007, Decatur

32610

Investigational Site Number 8400016, Gainesville

34390

Investigational Site Number 7920002, Istanbul

44789

Investigational Site Number 2760006, Bochum

48149

Investigational Site Number 2760002, Münster

48201

Investigational Site Number 8400001, Detroit

49933

Investigational Site Number 2500008, Angers

52242

Investigational Site Number 8400002, Iowa City

55131

Investigational Site Number 2760001, Mainz

55455

Investigational Site Number 8400019, Minneapolis

59037

Investigational Site Number 2500005, Lille

60611

Investigational Site Number 8400023, Chicago

63003

Investigational Site Number 2500010, Clermont-Ferrand

69677

Investigational Site Number 2500004, Bron

75013

Investigational Site Number 2500001, Paris

80131

Investigational Site Number 3800007, Napoli

80336

Investigational Site Number 2760003, München

84132

Investigational Site Number 8400018, Salt Lake City

85013

Investigational Site Number 8400015, Phoenix

90095

Investigational Site Number 8400020, Los Angeles

92868

Investigational Site Number 8400011, Orange

94305

Investigational Site Number 8400017, Stanford

97239

Investigational Site Number 8400014, Portland

98125

Investigational Site Number 3800001, Messina

125367

Investigational Site Number 6430001, Moscow

66160-7321

Investigational Site Number 8400012, Kansas City

02114

Investigational Site Number 8400010, Boston

45267-0542

Investigational Site Number 8400009, Cincinnati

C1181ACH

Investigational Site Number 0320001, Caba

71625-009

Investigational Site Number 0760004, Brasília

04037-002

Investigational Site Number 0760001, São Paulo

L8N 3Z5

Investigational Site Number 1240003, Hamilton

H3A 2B4

Investigational Site Number 1240002, Montreal

Unknown

Investigational Site Number 2500007, Bordeaux

Investigational Site Number 3920002, Kodaira-Shi

Investigational Site Number 4840001, México

3015 GE

Investigational Site Number 5280001, Rotterdam

02-097

Investigational Site Number 6160001, Warsaw

4710-243

Investigational Site Number 6200001, Braga

03080

Investigational Site Number 4100001, Seoul

06273

Investigational Site Number 4100002, Seoul

08025

Investigational Site Number 7240002, Barcelona

08950

Investigational Site Number 7240003, Barcelona

06100

Investigational Site Number 7920001, Ankara

B15 2GW

Investigational Site Number 8260005, Birmingham

CB2 OQQ

Investigational Site Number 8260002, Cambridge

NW3 2QG

Investigational Site Number 8260001, London

NE1 4LP

Investigational Site Number 8260004, Newcastle upon Tyne

M6 8HD

Investigational Site Number 8260003, Salford

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT02782741 - Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease | Biotech Hunter | Biotech Hunter