A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

March 11, 2022

Primary Completion Date

December 7, 2025

Study Completion Date

January 4, 2027

Conditions
Fabry Disease
Interventions
DRUG

Venglustat (GZ402671)

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Trial Locations (58)

1090

Investigational Site Number: 0400001, Vienna

2100

Investigational Site Number: 2080001, Copenhagen

3050

Investigational Site Number : 0360001, Parkville

5021

Investigational Site Number: 5780001, Bergen

8091

Investigational Site Number : 7560001, Zurich

10532

Westchester Medical Center Healthcare Corporation- Site Number : 8400001, Hawthorne

15213

Children's Hospital Of Pittsburgh- Site Number : 8400009, Pittsburgh

20052

Fondazione IRCCS San Gerardo dei Tintori, S.C. Nefrologia - Clinica Nefrologica_Investigational Site Number: 3800002, Monza

22030

Lysosomal and Rare Disorders Research and Treatment Center_Investigational Site Number: 8400004, Fairfax

22328

Institutul Clinic Fundeni_Investigational Site Number: 6420001, Bucharest

30322

Emory Genetics- Site Number : 8400010, Atlanta

32804

Advent Health Orlando_Investigational Site Number: 8400008, Orlando

35233

Nephrology Clinic at Kirklin Clinic of UAB Hospital_Investigational Site Number: 8400011, Birmingham

40138

IRCCS Policlinico di Sant'Orsola_Investigational Site Number : 3800005, Bologna

41000

Investigational Site Number : 7920002, İzmit

44195

Cleveland Clinic Site Number : 8400016, Cleveland

44280

Investigational Site Number : 7920004, Malatya

55131

Investigational Site Number : 2760005, Mainz

64460

"Hospital Universitario Dr. José Eleuterio González Departamento de Genética Centro Universitario contra el cáncer_Investigational Site Number: 4840001", Monterrey

65239

ISphinCS GmbH_Investigational Site Number: 2760004, Hochheim am Main

75235

Renal Disease Research Institute, An affiliate of: Dallas Nephrology Associates_Investigational Site Number: 8400012, Dallas

80138

"Azienda Ospedaliera Universitaria Federico II, U.O. di Nefrologia- Diparimento di Sanità Pubblica_Investigational Site Number: 3800001", Napoli

80336

Investigational Site Number: 2760003, München

84132

University Of Utah Health Sciences Center- Site Number : 8400005, Salt Lake City

90095

UCLA Medical Center_Investigational Site Number: 8400006, Los Angeles

90127

Azienda Ospedaliera Universitaria_Investigational Site Number: 3800003, Palermo

92380

Investigational Site Number : 2500001, Garches

92868

University of California Irvine Medical Center- Site Number : 8400019, Orange

97080

Investigational Site Number: 2760001, Würzburg

100034

No.8, Xishiku Street, Xicheng District_Site Number: 1560001, Beijing

200010

No.197,2nd Ruijin road, Huangpu district_Site Number: 1560003, Shanghai

450052

Investigational Site Number : 1560006, Zhengzhou

45229-3026

Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400013, Cincinnati

F5300

Fundacion Cori para la Investigación y Prevención del Cancer_Investigational Site Number: 0320002, La Rioja

B1878GEG

Instituto de Investigaciones Clínicas Quilmes (IICQ) SRL_Investigational Site Number: 0320003, Quilmes

90035-903

Hospital de Clínicas de Porto Alegre_Investigational Site Number: 0760001, Porto Alegre

04020-041

Instituto de Genética e Erros Inatos do Metabolismo - IGEIM- Site Number : 0760002, São Paulo

T2E7Z4

M.A.G.I.C Calgary LTD_Investigational Site Number: 1240003, Calgary

B3H 2Y9

Medicine Dalhousie University_Investigational Site Number : 1240001, Halifax

M5T 3L9

University Health Network_Investigational Site Number : 1240005, Toronto

030001

No.85 South Jiefang road, Yingze District_Site Number: 1560004, Taiyuan

FI-20520

Investigational Site Number: 2460001, Turku

115 28

Investigational Site Number : 3000003, Athens

711 10

University Hospital of Heraklion_Investigational Site Number: 3000001, Heraklion

455 00

University Hospital of Ioannina_Investigational Site Number: 3000002, Ioannina

00168

Fondazione Policlinico Universitario_Investigational Site Number: 3800004, Roma

215-0026

Investigational Site Number : 3920005, Kawasaki

814-0180

Fukuoka University Hospital_Investigational Site Number: 3920004, Fukuoka-shi, Fukuoka

105-8471

The Jikei University Hospital_Investigational Site Number: 3920003, Minato-ku, Tokyo

980-8574

Tohoku University Hospital_Investigational Site Number: 3920001, Sendai-shi, Miyagi

06700

Odette del Carmen DIAZ-AVENDAÑO Clinstile, S.A. de C.V. Durango_Investigational Site Number: 4840002, Mexico City

60-780

Investigational Site Number : 6160002, Poznan

35-301

Investigational Site Number : 6160004, Rzeszów

50-556

Investigational Site Number: 6160003, Wroclaw

06560

Investigational Site Number : 7920001, Ankara

CB2 2QQ

Investigational Site Number: 8260001, Cambridge

NW3 2QG

Investigational Site Number: 8260002, London

M6 8HD

Investigational Site Number : 8260003, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY

NCT05206773 - A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease | Biotech Hunter | Biotech Hunter