Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
Study Identifier:
PB-102-F20
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)
- Biological: agalsidase beta
Date
Jun 2016 - Oct 2021
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 was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.
Study Locations
Location
Status
Location
UAB Medicine
Birmingham, Alabama, United States, 35233
Status
N/A
Location
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
N/A
Location
University of California Irvine Center
Orange, California, United States, 92868
Status
N/A
Location
University of California San Diego
San Diego, California, United States, 92093
Status
N/A
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Status
N/A
Location
University of Iowa Hosptials and Clinics
Iowa City, Iowa, United States, 52242
Status
N/A