CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Agalsidase betabiological
Likely dose
Agalsidase beta 1.0 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/NCT01650779
NCT01650779Phase 4Completed
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Evaluation of Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta (The INFORM Study)

Genzyme, a Sanofi Company·interventional·Posted Jul 26, 2012·Updated Jul 10, 2014

In Brief

A Phase 4 clinical trial evaluating Agalsidase beta for Fabry Disease. Completed, enrolled 15 participants across 6 sites.

Detailed Summary

This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartApr 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.9 years ago

Interventions

Agalsidase betabiological

Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.