At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
PRX-102 (pegunigalsidase alfa)biological
Likely dose
PRX-102 (pegunigalsidase alfa) 1 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.
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients
In Brief
A Phase 2 clinical trial evaluating PRX-102 (pegunigalsidase alfa) for Fabry Disease. Completed, enrolled 15 participants across 8 sites in 4 countries.
Detailed Summary
To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesParaguay, Spain, United Kingdom, United States
CollaboratorsChiesi Farmaceutici S.p.A.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartJan 2014
Primary CompletionAug 2020
Study CompletionNov 2021
TodayJul 2026
First PostedNov 11, 2013
Enrollment StartJan 16, 2014
Primary CompletionAug 26, 2020
Study CompletionNov 9, 2021
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 12.6 years ago
Interventions
PRX-102 (pegunigalsidase alfa)biological
PRX-102 1 mg/kg every 2 weeks