A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

August 31, 2029

Study Completion Date

November 30, 2029

Conditions
Fabry Disease
Interventions
DRUG

Lucerastat

Administered in hard gelatin capsules containing 250 mg of lucerastat.

Trial Locations (42)

1090

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse, Vienna

3000

University Hospital Gasthuisberg, Leuven (UZ Leuven), Leuven

3050

Royal Melbourne Hospital - Department of Nephrology, Parkville

5021

Haukeland University Hospital, Bergen

6000

Royal Perth Hospital, Department of Nephrology, Perth

8032

Psychiatrische Universitätsklinik Zürich, Zurich

9000

University Hospital Ghent (UZ Ghent), Ghent

10117

Universitätsmedizin Berlin - Charité Campus Mitte, Berlin

19104

University of Pennsylvania - Dept of Medicine, Philadelphia

22030

Lysosomal and Rare Disorders Research and Treatment Center, Inc., Fairfax

28034

Hospital Universitario Ramon y Cajal. Servicio de Medicina Interna, Madrid

29605

Greenwood Genetics Center, Greenville

32610

University of Florida Clinical and Translational Science Institute, UF Clinical Research Center, Gainesville

35294

University of Alabama at Birmingham - Nephrology Research Clinic, Birmingham

49525

Infusion Associates, Grand Rapids

50012

Hospital Quironsalud Zaragoza, Zaragoza

52242

University of Iowa Stead Family Children's Hospital - Division of Medical Genetics, Iowa City

60612

Rush University Medical Center - Dept of Pediatrics, Chicago

65239

SphinCS GmbH, Höchheim

75204

Renal Disease Research Institute LLC, Dallas

75246

Baylore University Medical Center, Dallas

79379

Nephrologicum Markgräflerland MVZ GmbH, Müllheim

84108

University of Utah - Division of Medical Genetics, Clinical Genetics Research, Salt Lake City

92380

Raymond Poincaré Hosp - Med Genetics Dept, Garches

92697

University of California Irvine, Irvine

94609

UCSF Benioff Children's Hospital Oakland, Oakland

97080

Universitätsklinikum Würzburg, Würzburg

02114

Massachusetts General Hospital, Boston

T2N 4Z6

University of Calgary - Heritage Medical Research Clinic, Calgary

N6A 5W9

London Health Sciences CTR, Victoria Hospital, London

H4J 1C5

Research Center, Hôpital du Sacré-Coeur de Montréal, Montreal

V5Z 1M9

Vancouver General Hospital - Adult Metabolic Diseases Clinic, Vancouver

R3E 3P4

Children's Hospital Research Institute of Manitoba, Winnipeg

1105 AZ

Hospital Academisch Medisch Centrum - Department of Internal Medicine, Div. Endrocrinology and Metabolism, Amsterdam

31-066

Clinic of Immunological Diseases and Blood Coagulability Cracow University Hospital, Krakow

04-628

Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy, Warsaw

04-730

The Children's Memorial Health Institute, Department of Pediatric, Nutrition and Metabolic Diseases, Warsaw

08035

Vall d'Hebron University Hospital - Unit of Inherited Metabolic Disorders and Rare Diseases, Barcelona

08907

Hospital Universitari de Bellvitge / Nephrology Dpt, Barcelona

NW3 2QG

Royal Free London NHS Foundation Trust Lysosomal Storage Disorder Unit; Department of Hematology, London

WC1N 3BG

National Hospital for Neurology and Neurosurgery, London

M6 8HD

Salford Hospital, Manchester

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY

NCT03737214 - A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease | Biotech Hunter | Biotech Hunter