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imiglucerase

DRUG6 trials

Sponsors

Genzyme Corp., Shire, Genzyme, a Sanofi Company, University Research Foundation for Lysosomal Storage Diseases, Inc., Sanofi

Conditions

Gaucher DiseaseGaucher Disease Type 1Gaucher Disease Type 3Gaucher Disease, Type 1Gaucher disease type 1Gaucher disease type 3Gaucher's Disease Type III

Phase 2

Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension
Active, not recruitingNCT02843035
Genzyme, a Sanofi CompanyGaucher Disease Type 1, Gaucher Disease Type 3
Start: 2017-01-04End: 2026-10-30Updated: 2025-03-26
A 4-part, open-label, multicenter, multinational study of the safety, tolerability, pharmacokinetics, pharmacodynamic, and exploratory efficacy of venglustat in combination with Cerezyme in adult patients with Gaucher disease Type 3 with venglustat monotherapy extension
CompletedCTIS2023-508646-18-00
Genzyme Corp.Gaucher disease type 1, Gaucher disease type 3
Start: 2017-09-18End: 2025-09-02Target: 3Updated: 2025-08-28

Phase 3

Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease
CompletedNCT00553631
ShireGaucher Disease, Type 1
Start: 2008-01-29End: 2009-05-05Updated: 2021-06-08
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
CompletedNCT00943111
Genzyme, a Sanofi CompanyGaucher Disease, Type 1
Start: 2009-09-30End: 2015-06-30Updated: 2016-11-25
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3
Active, not recruitingNCT05222906
SanofiGaucher's Disease Type III
Start: 2022-04-18End: 2026-10-30Updated: 2025-10-17

Unknown Phase

Validating a New Severity Score System for Adults With Type 1 Gaucher Disease (GD1)
CompletedNCT01136304
University Research Foundation for Lysosomal Storage Diseases, Inc.Gaucher Disease
Start: 2010-04-30End: 2013-12-31Updated: 2015-06-01

Related Papers

Qualitative Study of the Patient Experience with Venglustat for Gaucher Disease Type 3 in a Phase 2 Open-Label, Multicenter, Multinational Study (LEAP).
2024-05-277 citations
Pharmacokinetics, Safety, and Tolerability of Single-Dose Orally Administered Venglustat in Healthy Chinese Volunteers.
2023-06-031 citations
Venglustat combined with imiglucerase for neurological disease in adults with Gaucher disease type 3: the LEAP trial
Brain2022-10-1438 citations
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients with Parkinson’s Disease and a GBA Mutation: Results from Part 1 of the Randomized, Double-Blinded, Placebo-Controlled MOVES-PD Trial
Journal of Parkinson s Disease2021-12-1059 citations
Biomarker Response to Oral Eliglustat in Adults with Gaucher Disease Type 1: Results from 4 Completed Clinical Trials
Blood2019-11-13
Long-Term Effects of Oral Eliglustat on Skeletal Manifestations of Gaucher Disease Type 1: Results from Four Completed Clinical Trials
Blood2018-11-29
The Long-Term Adverse Event Profile of Oral Eliglustat for the Treatment of Gaucher Disease Type 1: Pooled Analysis of Data from 393 Patients in 4 Completed Trials
Blood2018-11-29
A new framework for evaluating the health impacts of treatment for Gaucher disease type 1
Orphanet Journal of Rare Diseases2017-02-2012 citations
Eliglustat maintains long-term clinical stability in patients with Gaucher disease type 1 stabilized on enzyme therapy
Blood2017-02-0790 citations
Treatment-naïve Gaucher disease patients achieve therapeutic goals and normalization with velaglucerase alfa by 4 years in phase 3 trials
Blood Cells Molecules and Diseases2016-10-2129 citations
Stability is maintained in adults with Gaucher disease type 1 switched from velaglucerase alfa to eliglustat or imiglucerase: A sub-analysis of the eliglustat ENCORE trial
Molecular Genetics and Metabolism Reports2016-10-0218 citations
Long-Term Hematologic Response to Eliglustat in Patients with Gaucher Disease Type 1: Results from a Phase 2 and Two Phase 3 Trials
Blood2015-12-03
Eliglustat compared with imiglucerase in patients with Gaucher's disease type 1 stabilised on enzyme replacement therapy: a phase 3, randomised, open-label, non-inferiority trial.
2015-03-26109 citations
Encore - a Randomized, Controlled, Open-Label Non-Inferiority Study Comparing Eliglustat to Imiglucerase in Gaucher Disease Type 1 Patients Stabilized on Enzyme Replacement Therapy: 24-Month Results
Blood2014-12-062 citations
Encore: A Randomized, Controlled, Open-Label Non-Inferiority Study Comparing Eliglustat To Imiglucerase In Gaucher Disease Type 1 Patients On Enzyme Replacement Therapy Who Have Reached Therapeutic Goals
Blood2013-11-156 citations