CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
velaglucerase 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/NCT01685216
NCT01685216Phase 2Completed

A Multi-center, Open-label, Efficacy and Safety Study of Velaglucerase Alfa Enzyme Replacement Therapy in Children and Adolescents With Type 3 Gaucher Disease

Shire·interventional·Posted Sep 14, 2012·Updated Jun 11, 2021

In Brief

A Phase 2 clinical trial evaluating velaglucerase alfa for Gaucher Disease, Type 3. Completed, enrolled 7 participants across 5 sites in 3 countries.

Detailed Summary

Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Gaucher disease has been classified into 3 clinical subtypes based on the presence or absence of neurological symptoms and the severity of these neurological symptoms. Patients with type 2 Gaucher disease present with acute neurological deterioration, and those with type 3 disease typically display a more sub acute neurological course. Type 1 Gaucher disease, the most common form accounting for more than 90% of all Gaucher disease cases, does not involve the central nervous system. The purpose of this clinical research study is to investigate the safety and effectiveness of velaglucerase alfa in patients with type 3 Gaucher disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt, India, Tunisia
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2012
Enrollment StartSep 14, 2012
Primary CompletionMar 15, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.8 years ago

Interventions

velaglucerase alfabiological

lyophilized powder, intravenous infusion, units, Every other week (EOW)