CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Eliglustat, GZ385660drug
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/NCT02536755
NCT02536755Phase 3Completed
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Open Label Interventional Multicenter Phase 3b Study to Evaluate Skeletal Response to Eliglustat in Adult Patients Who Successfully Completed the Phase 2 or Phase 3 Studies

Genzyme, a Sanofi Company·interventional·Posted Sep 1, 2015·Updated Jul 15, 2022

In Brief

A Phase 3 clinical trial evaluating Eliglustat, GZ385660 for Gaucher Disease. Completed, enrolled 31 participants across 4 sites in 3 countries.

Detailed Summary

Primary Objective: Evaluate long term skeletal response to eliglustat in adult participants who successfully completed one of the Phase 2 or Phase 3 eliglustat studies. Secondary Objective: Evaluate the safety of eliglustat (by serious adverse event continuous monitoring), the quality of life (Short Form-36 Health Survey \[SF-36\]) and biomarkers of Gaucher disease type 1 (GD1) (chitotriosidase, plasma glucosylceramide \[GL-1\] and lyso glucosylceramide \[lyso-GL-1\]) in adult participants who successfully completed one of the Phase 2 or Phase 3 studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesCanada, Russia, Tunisia
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 1, 2015
Enrollment StartOct 27, 2015
Primary CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.8 years ago

Interventions

Eliglustat, GZ385660drug

Pharmaceutical form: capsule Route of administration: oral