Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

Study Identifier:
CLI-06657AA1-03
ClinicalTrials.gov Identifier:
NCT03614234
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Active, not recruiting

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: pegunigalsidase alfa
Date
Nov 2018 - Dec 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Healthy Volunteers
No

Protocol Summary

The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.

Study Locations

Location
Status
Location
UAB Medicine
Birmingham, Alabama, United States, 35233
Status
N/A
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30307
Status
N/A
Location
University of Iowa Hospitals and Clinica
Iowa City, Iowa, United States, 52242
Status
N/A
Location
Infusion Associates
Grand Rapids, Michigan, United States, 49525
Status
N/A
Location
Renal Disease Research Institute, LLC
Dallas, Texas, United States, 75235
Status
N/A
Location
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States, 84112
Status
N/A