Last updated on February 2018

Safety and Efficacy of PRX 102 in Patients With Fabry Disease Currently Treated With REPLAGAL (Agalsidase Alfa)


Brief description of study

This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80% labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3 months while continuing on agalsidase alfa. Following the screening period, the patient will be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated patients will be female.

Clinical Study Identifier: NCT03018730

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Kathleen Nicholls, MD

Royal Melbourne Hospital
Parkville, Australia
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Michael West, MD

Capital Health
Halifax, NS Canada
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Ales Linhart, MD

Vseobecna fakultni nemocnice v Praze
Prague, Czechia
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Christoph Wanner, MD

Universitaetsklinikum Wuerzburg
Wurzburg, Germany
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Mirjam Langeveld, MD

Academisch Medisch Centrum
Amsterdam, Netherlands
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Camilla Tøndel, MD

Helse Bergen HF Haukeland Universitetssykehus
Bergen, Norway
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Pilar Giraldo, MD

Hospital de Dia Quiron Zaragoza
Zaragoza, Spain
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Patrick Deegan, MD

Addenbrooke's Hospital
Cambridge, United Kingdom
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Derralynn Hughes, MD

The Royal Free Hospital
London, United Kingdom
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Ana Jovanovic, MD

Salford Royal NHS Foundation Trust
Salford, United Kingdom
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Bojan Vujkovac, MD

General Hospital Slovenj Gradec
Slovenj Gradec, Slovenia
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Tarekegn G Hiwot, MD

Institute of Metabolism and Systems Research
Edgbaston, United Kingdom
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