Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

PHASE3CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

October 31, 2021

Study Completion Date

July 31, 2022

Conditions
Fabry Disease
Interventions
BIOLOGICAL

PRX-102 (pegunigalsidase alfa)

PRX-102 1 mg/kg every 2 weeks

BIOLOGICAL

agalsidase beta

agalsidase beta 1 mg/kg every 2 weeks

Trial Locations (29)

1083

Semmelweis Egyetem, Budapest

2380

General Hospital Slovenj Gradec, Slovenj Gradec

5021

Haukeland University Hospital Klinisk Forskningspost, Bergen

12808

Vseobecna fakultni nemocnice v Praze, Prague

15224

Children's Hospital of Pittsburgh, Pittsburgh

20520

Turku University Central Hospital, Turku

22030

O+O Alpan LLC, Fairfax

30322

Emory University School of Medicine, Atlanta

35233

UAB Medicine, Birmingham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

49525

Infusion Associates, Grand Rapids

50012

Hospital de Dia Quiron Zaragoza, Zaragoza

52242

University of Iowa Hosptials and Clinics, Iowa City

75226

Institute of Metabolic Disease, Baylor Healthcare, Dallas

75235

Renal Disease Research Institute, LLC - Dallas, Dallas

84132

Eccles Primary Children's Outpatient Services Building, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

92093

University of California San Diego, San Diego

92380

Hôpital Raymond Poincaré, Paris

92868

University of California Irvine Center, Orange

02114

Massachusetts General Hospital, Boston

53226-3596

Medical College of Wisconsin, Milwaukee

Unknown

"Azienda Ospedaliera Universitaria Federico II", Napoli

Klinik und Poliklinik für Innere Medizin UniversitätsSpital Zürich, Zurich

Institute of Metabolism and Systems Research, Edgbaston

1105 AZ

Academisch Medisch Centrum, Amsterdam

CB2 0QQ

Addenbrooke's Hospital, Cambridge

NW3 2QG

The Royal Free Hospital, London

M6 8HD

Salford Royal NHS Foundation Trust, Salford

All Listed Sponsors
collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

lead

Protalix

INDUSTRY

NCT02795676 - Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function | Biotech Hunter | Biotech Hunter