Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks
Completed · Phase 3
Conditions studied: Fabry Disease
In brief
This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3 years. Safety and efficacy exploratory endpoints will be evaluated throughout the study period and pharmacokinetics will be obtained on Day 1 and Week 52.
Key facts
- Study ID
- NCT03180840
- Run by
- Protalix
- People needed
- 30
- Starts
- 2017-07-10
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2023-09-13
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UAB Medicine — Birmingham, Alabama, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Infusion Associates — Grand Rapids, Michigan, United States
- Institute of Metabolic Disease — Dallas, Texas, United States
- University of Utah Hospital & Clinics — Salt Lake City, Utah, United States
- O & O Alpan — Fairfax, Virginia, United States
- UZ Antwerpen — Edegem, Belgium
- Fakultní poliklinika Všeobecné fakultní nemocnice v Praze — Prague, Czechia
- Rigshospitalet — Copenhagen, Denmark
- Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy
- Helse Bergen HF Haukeland Universitetssykehus — Bergen, Norway
- Addenbrooke's Hospital — Cambridge, United Kingdom
- The Royal Free Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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