Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease

Study Identifier:
CLI-06657AA1-04
ClinicalTrials.gov Identifier:
NCT03566017
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: pegunigalsidase alfa
Date
Sep 2018 - Jan 2025
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

The objective of CLI-06657AA1-04 (formerly PB-102-F60) is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who have successfully completed studies PB-102-F03, PB-102-F20 or PB-102-F30.

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 San Diego
La Jolla, California, United States, 92037
Status
N/A
Location
University of California Irvine Center
Orange, California, United States, 92868
Status
N/A
Location
University of Florida
Gainesville, Florida, United States, 32610
Status
N/A
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Status
N/A