CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 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.

Search/NCT03018730
NCT03018730Phase 3Completed
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An Open Label Study of the Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)

Protalix·interventional·Posted Jan 12, 2017·Updated Sep 13, 2023

In Brief

A Phase 3 clinical trial evaluating PRX-102 (pegunigalsidase alfa) for Fabry Disease. Completed, enrolled 22 participants across 9 sites in 7 countries.

Detailed Summary

This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a stable dose (\>80% labelled dose/kg) for at least 6 months. Patients will be screened and evaluated over 3 months while continuing on agalsidase alfa. Following the screening period, the patient will be enrolled and switched from their agalsidase alfa treatment to receive intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25% of treated patients will be female.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Canada, Czechia, Netherlands, Norway, Slovenia, United Kingdom
CollaboratorsChiesi Farmaceutici S.p.A.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartMay 17, 2017
Primary CompletionDec 17, 2019
Study CompletionJan 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.5 years ago

Interventions

PRX-102 (pegunigalsidase alfa)biological

PRX-102 1 mg/kg every 2 weeks