At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 97 enrolled
Drug / intervention
pegunigalsidase alfadrug
Likely dose
Not stated in 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.
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease
In Brief
A Phase 3 clinical trial evaluating pegunigalsidase alfa for Fabry Disease. Completed, enrolled 97 participants across 30 sites in 13 countries.
Detailed Summary
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was 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 had successfully completed studies PB-102-F20, PB-102-F30, or at least 48 months in study PB-102-F03.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Canada, Czechia, Finland, France, Hungary, Italy, Netherlands, Norway, Slovenia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartSep 2018
Primary CompletionJan 2025
TodayJul 2026
First PostedJun 21, 2018
Enrollment StartSep 16, 2018
Primary CompletionJan 21, 2025
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 8.0 years ago
Interventions
pegunigalsidase alfadrug
Recombinant human alpha galactosidase A