At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Pegunigalsidase alfabiological
Likely dose
Pegunigalsidase alfa 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Open-Label Switch Over Study to Assess Safety, Efficacy & PK of Pegunigalsidase Alfa (PRX-102) 2mg/kg IV Every 4 Weeks for 52 Weeks in Fabry Disease Patients Currently Treated With Enzyme Replacement Therapy Fabrazyme® or Replagal™
In Brief
A Phase 3 clinical trial evaluating Pegunigalsidase alfa for Fabry Disease. Completed, enrolled 30 participants across 14 sites in 7 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesBelgium, Czechia, Denmark, Italy, Norway, United Kingdom, United States
CollaboratorsChiesi Farmaceutici S.p.A.
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 2017
Enrollment StartJul 2017
Primary CompletionAug 2020
TodayJul 2026
First PostedJun 8, 2017
Enrollment StartJul 10, 2017
Primary CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.1 years ago
Interventions
Pegunigalsidase alfabiological
Pegunigalsidase alfa 2 mg/kg every 4 weeks