At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
PRX-102drug
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.
A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Months to Adult Fabry Patients
In Brief
A Phase 2 clinical trial evaluating PRX-102 for Fabry Disease. Completed, enrolled 18 participants across 14 sites in 6 countries.
Detailed Summary
This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Paraguay, Serbia, Spain, United Kingdom, United States
CollaboratorsChiesi Farmaceutici S.p.A.
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartOct 2012
Primary CompletionMar 2016
TodayJul 2026
First PostedSep 5, 2012
Enrollment StartOct 1, 2012
Primary CompletionMar 6, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.8 years ago
Interventions
PRX-102drug