A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

May 3, 2022

Primary Completion Date

May 15, 2026

Study Completion Date

December 6, 2027

Conditions
Fabry Disease
Interventions
DRUG

Venglustat (GZ402671)

Tablet; Oral

DRUG

Agalsidase alfa

Concentrate for solution for infusion; IV infusion

DRUG

Agalsidase beta (GZ419828)

Powder for concentrate for solution for infusion; IV infusion

DRUG

Migalastat

Hard capsules; Oral

Trial Locations (54)

104

Investigational Site Number : 1580001, Taipei

407

Investigational Site Number : 1580003, Taichung

2100

Investigational Site Number : 2080001, Copenhagen

5021

Investigational Site Number : 5780001, Bergen

8036

Investigational Site Number : 0400001, Graz

10117

Investigational Site Number : 2760003, Berlin

10532

Maryam Banikazemi, MD- Site Number : 8400001, Hawthorne

20122

Investigational Site Number : 3800001, Milan

22030

Lysosomal and Rare Disorders Research and Treatment Center (LDRTC)- Site Number : 8400004, Fairfax

28007

Investigational Site Number : 7240002, Madrid

30322

Emory University School of Medicine - Atlanta- Site Number : 8400009, Atlanta

34098

Investigational Site Number : 7920002, Istanbul

35233

University of Alabama -The Kirklin Clinic- Site Number : 8400010, Birmingham

36312

Investigational Site Number : 7240001, Pontevedra

40138

Investigational Site Number : 3800004, Bologna

41000

Investigational Site Number : 7920003, İzmit

50612

Investigational Site Number : 4100002, Yangsan

55131

Investigational Site Number : 2760005, Mainz

60611

Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400005, Chicago

65239

Investigational Site Number : 2760004, Hochheim am Main

75204

Renal Disease Research Institute- Site Number : 8400012, Dallas

80131

Investigational Site Number : 3800002, Naples

Investigational Site Number : 3800003, Naples

84132

University of Utah Health Hospital- Site Number : 8400006, Salt Lake City

90095

University of California Los Angeles Medical Center- Site Number : 8400008, Los Angeles

92380

Investigational Site Number : 2500001, Garches

97080

Investigational Site Number : 2760001, Würzburg

100034

Investigational Site Number : 1560002, Beijing

Investigational Site Number : 1560005, Beijing

200025

Investigational Site Number : 1560003, Shanghai

510080

Investigational Site Number : 1560007, Guangzhou

610041

Investigational Site Number : 1560001, Chengdu

T2M 0L6

Investigational Site Number : 1240003, Calgary

T6G 2B7

Investigational Site Number : 1240006, Edmonton

V5Z 1M9

Investigational Site Number : 1240002, Vancouver

M5T 3H7

Investigational Site Number : 1240005, Toronto

128 08

Investigational Site Number : 2030001, Prague

115 27

Investigational Site Number : 3000002, Athens

124 62

Investigational Site Number : 3000003, Athens

711 10

Investigational Site Number : 3000001, Heraklion

060-8648

Investigational Site Number : 3920006, Sapporo

890-0064

Investigational Site Number : 3920007, Kagoshima

890-8520

Investigational Site Number : 3920003, Kagoshima

215-0026

Investigational Site Number : 3920005, Kawasaki

980-8574

Investigational Site Number : 3920002, Sendai

814-0180

Investigational Site Number : 3920004, Fukuoka

105-8461

Investigational Site Number : 3920001, Tokyo

1105 AZ

Investigational Site Number : 5280001, Amsterdam

02-213

Investigational Site Number : 6160003, Lodz

31-202

Investigational Site Number : 6160001, Krakow

03722

Investigational Site Number : 4100001, Seoul

03010

Investigational Site Number : 7240003, Alicante

06560

Investigational Site Number : 7920001, Ankara

NW3 2QG

Investigational Site Number : 8260001, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT05280548 - A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease | Biotech Hunter | Biotech Hunter