Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
Study Identifier:
PB-102-F30
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Unmapped
Available Languages: English
Study Details
Medical Condition
- Fabry Disease
Study Drug
- Biological: PRX-102 (pegunigalsidase alfa)
Date
May 2017 - Dec 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Healthy Volunteers
No
Protocol Summary
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.
Study Locations
Location
Status
Location
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Status
N/A
Location
Capital Health
Halifax, Nova Scotia, Canada, B3H 1V8
Status
N/A
Location
Vseobecna fakultni nemocnice v Praze
Prague, Czech Republic
Status
N/A
Location
Academisch Medisch Centrum
Amsterdam, Netherlands
Status
N/A
Location
Helse Bergen HF Haukeland Universitetssykehus
Bergen, Norway
Status
N/A
Location
General Hospital Slovenj Gradec
Slovenj Gradec, Slovenia, SI-2380
Status
N/A