CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
agalsidase alfabiological
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.

Search/NCT01304277
NCT01304277Phase 2Completed

A Phase II Comparability Study Between Replagal® Produced From Agalsidase Alfa Manufactured by 2 Different Processes in Adult Male Patients With Fabry Disease

Shire·interventional·Posted Feb 25, 2011·Updated Jul 19, 2021

In Brief

A Phase 2 clinical trial evaluating agalsidase alfa for Fabry Disease. Completed, enrolled 17 participants across 5 sites.

Detailed Summary

This study is designed to evaluate safety and PK/PD in Canadian Fabry patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2011
Enrollment StartNov 17, 2011
Primary CompletionDec 28, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.4 years ago

Interventions

agalsidase alfabiological