Eliglustat ( DrugBank: Eliglustat )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 19 | ライソゾーム病 | 26 |
19. ライソゾーム病
臨床試験数 : 854 / 薬物数 : 716 - (DrugBank : 105) / 標的遺伝子数 : 70 - 標的パスウェイ数 : 191
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000301-37-NL (EUCTR) | 06/03/2019 | 28/06/2018 | Safety and Efficacy of Eliglustat with or without Imiglucerase in Pediatric Patients with Gaucher Disease (GD) Type 1 and Type 3 | Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3 - ELIKIDS | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075699;Term: Gaucher's disease type III;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cerdelga Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Trade Name: Cerezyme Product Name: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Cerezyme Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Egypt;Canada;Argentina;Spain;Turkey;Russian Federation;Netherlands;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2016-000301-37-GB (EUCTR) | 09/01/2019 | 17/06/2019 | Safety and Efficacy of Eliglustat with or without Imiglucerase in Pediatric Patients with Gaucher Disease (GD) Type 1 and Type 3 | Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3 - ELIKIDS | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075699;Term: Gaucher's disease type III;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cerdelga Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Trade Name: Cerezyme Product Name: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Cerezyme Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Egypt;Canada;Argentina;Spain;Turkey;Russian Federation;Netherlands;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2016-000301-37-SE (EUCTR) | 09/10/2018 | 05/06/2018 | Safety and Efficacy of Eliglustat with or without Imiglucerase in Pediatric Patients with Gaucher Disease (GD) Type 1 and Type 3 | Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3 - ELIKIDS | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075699;Term: Gaucher's disease type III;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cerdelga Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Trade Name: Cerezyme Product Name: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Cerezyme Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 Other descriptive name: Eliglustat Tartrate – Powder for Oral Suspension | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | Taiwan;Spain;Turkey;Russian Federation;Italy;United Kingdom;Egypt;France;Canada;Argentina;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2016-000301-37-IT (EUCTR) | 02/07/2018 | 20/06/2018 | Safety and Efficacy of Eliglustat with or without Imiglucerase in Pediatric Patients with Gaucher Disease (GD) Type 1 and Type 3 | Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3 - ELIKIDS | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075699;Term: Gaucher's disease type III;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cerdelga Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Trade Name: Cerezyme Product Name: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Cerezyme Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | France;Egypt;Canada;Argentina;Spain;Turkey;Russian Federation;Netherlands;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2016-000301-37-ES (EUCTR) | 21/06/2018 | 06/07/2018 | Safety and Efficacy of Eliglustat with or without Imiglucerase in Pediatric Patients with Gaucher Disease (GD) Type 1 and Type 3 | Open label, Two Cohort (with and without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients with Gaucher Disease Type 1 and Type 3 - ELIKIDS | Congenital, hereditary and neonatal diseases MedDRA version: 20.0;Level: PT;Classification code 10075697;Term: Gaucher's disease type I;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10075699;Term: Gaucher's disease type III;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cerdelga Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Trade Name: Cerezyme Product Name: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Cerezyme Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE Product Name: Eliglustat Product Code: GZ385660 INN or Proposed INN: Eliglustat Other descriptive name: ELIGLUSTAT TARTRATE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | France;Egypt;Canada;Argentina;Spain;Turkey;Russian Federation;Netherlands;Italy;United Kingdom;Sweden | ||
| 6 | NCT03519646 (ClinicalTrials.gov) | April 23, 2018 | 20/3/2018 | Eliglustat on Gaucher Disease Type IIIB | Evaluation of the Safety in the Combination Usage of Cerdelga and Cerezyme in Type III Gaucher Disease Patients and the Efficacy on Soft Tissue Diseases. | Gaucher Disease, Type III | Drug: Eliglustat | National Taiwan University Hospital | Sanofi | Active, not recruiting | 6 Years | N/A | All | 4 | N/A | Taiwan |
| 7 | NCT03485677 (ClinicalTrials.gov) | April 11, 2018 | 23/3/2018 | Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3 | Open Label, Two Cohort (With and Without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients With Gaucher Disease Type 1 and Type 3 | Gaucher's Disease Type I;Gaucher's Disease Type III | Drug: Eliglustat GZ385660;Drug: Imiglucerase GZ437843 | Sanofi | NULL | Recruiting | 2 Years | 17 Years | All | 60 | Phase 3 | Argentina;Canada;France;Italy;Japan;Russian Federation;Spain;Sweden;Turkey;United Kingdom |
| 8 | NCT02536755 (ClinicalTrials.gov) | October 28, 2015 | 27/8/2015 | Study of Skeletal Response to Eliglustat in Patients With Gaucher Disease | 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 | Gaucher's Disease | Drug: eliglustat GZ385660 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | All | 31 | Phase 3 | Canada;Russian Federation;Tunisia |
| 9 | NCT02536911 (ClinicalTrials.gov) | September 2015 | 28/8/2015 | A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate | An Open-label Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function | Gaucher Disease | Drug: eliglustat | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 79 Years | All | 24 | Phase 1 | United States |
| 10 | NCT02536937 (ClinicalTrials.gov) | September 2015 | 28/8/2015 | A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate | An Open-label Two-stage Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function | Gaucher Disease | Drug: eliglustat | Sanofi | NULL | Completed | 18 Years | 79 Years | All | 32 | Phase 1 | United States |
| 11 | NCT02422654 (ClinicalTrials.gov) | April 2015 | 14/4/2015 | Taste Evaluation of Different Liquid Formulations With Eliglustat | A Single-blind, Randomized, Unbalanced Crossover Design With 5 Vehicles, 5 Periods, and 5 Sequences, Repeated-doses (With no Ingestion) Study to Assess the Palatability of Eliglustat Prototype Liquid Formulations in Healthy Subjects | Gaucher Disease | Drug: eliglustat | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 55 Years | Both | 8 | Phase 1 | United States |
| 12 | EUCTR2009-015811-42-PT (EUCTR) | 04/02/2011 | 09/11/2010 | A study with Eliglustat Tartrate (Genz-112638) in Patients with Gaucher disease to Evaluate Once Daily Dosing versus Twice Daily | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1 who have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 - EDGE | Gaucher Disease Type I MedDRA version: 14.1;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | United States;Serbia;Portugal;Greece;Austria;Russian Federation;India;France;Canada;Argentina;Brazil;Romania;Croatia;Australia;Netherlands;China;Japan;Sweden | ||
| 13 | EUCTR2009-015811-42-GR (EUCTR) | 25/01/2011 | 19/05/2011 | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1 who have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 - EDGE | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1 who have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 - EDGE | Gaucher Disease Type I MedDRA version: 12.1;Level: PT;Classification code 10018048;Term: Gaucher's disease | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Portugal;Greece;Austria;Sweden | ||
| 14 | EUCTR2009-015811-42-AT (EUCTR) | 05/01/2011 | 22/11/2010 | A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE) | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1 who have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 - EDGE | Gaucher Disease Type I MedDRA version: 15.0;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Portugal;Serbia;United States;Greece;Austria;Russian Federation;India;France;Canada;Argentina;Brazil;Romania;Croatia;Australia;Netherlands;Japan;China;Sweden | ||
| 15 | EUCTR2009-015811-42-SE (EUCTR) | 20/12/2010 | 01/11/2010 | A study of Eliglustat Tartrate (Genz-112638) in Patients with Gaucher Disease to Evaluate Once Daily versus Twice Daily Dosing | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once Daily versus Twice Daily Dosing of Genz-112638 in Patients with Gaucher Disease Type 1 who have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 - EDGE | Gaucher Disease Type I MedDRA version: 16.0;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Portugal;Serbia;United States;Greece;Austria;Russian Federation;India;France;Canada;Argentina;Brazil;Romania;Croatia;Australia;Netherlands;Japan;China;Sweden | ||
| 16 | NCT01074944 (ClinicalTrials.gov) | June 2010 | 23/2/2010 | A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE) | A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once Daily Versus Twice Daily Dosing of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638 | Gaucher Disease | Drug: Eliglustat tartrate | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | All | 170 | Phase 3 | United States;Australia;Austria;Brazil;Canada;China;Croatia;France;Greece;India;Japan;Netherlands;Portugal;Romania;Russian Federation;Serbia;Sweden |
| 17 | EUCTR2008-005222-37-BG (EUCTR) | 10/02/2010 | 11/11/2009 | A study with Eliglustat Tartrate (Genz-112638) in Patients With GaucherDisease | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 - ENGAGE | Gaucher Disease type I MedDRA version: 16.1;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 3 | United States;Serbia;Saudi Arabia;Lebanon;Israel;Russian Federation;Colombia;United Kingdom;India;Mexico;Canada;Jordan;Bulgaria;Netherlands;Tunisia | ||
| 18 | EUCTR2008-005223-28-DE (EUCTR) | 21/01/2010 | 11/08/2009 | A Study of Eliglustat Tartrate (Genz-112638) in Patients with Gaucher Disease Who Have Reached Thereapeutic Goals with Enzyme Replacement Therapy | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have reached therapeutic goals with enzyme replacement therapy - ENCORE | Gaucher Disease type I MedDRA version: 18.0;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Trade Name: Cerezyme Product Name: Cerezyme Product Code: imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Recombinant human derived macrophage-targeted ß-Glucocerebrosidase Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;Egypt;France;Czech Republic;Canada;Argentina;Brazil;Australia;Netherlands;Germany | ||
| 19 | EUCTR2008-005223-28-GB (EUCTR) | 16/11/2009 | 06/07/2009 | A Study of Eliglustat Tartrate (Genz-112638) in Patients with Gaucher Disease Who Have Reached Thereapeutic Goals with Enzyme Replacement Therapy | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached Therapeutic Goals with Enzyme Replacement Therapy - ENCORE | Gaucher Disease type I MedDRA version: 14.1;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Trade Name: Cerezyme Product Name: Cerezyme Product Code: imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Recombinant human derived macrophage-targeted ß-Glucocerebrosidase | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;Egypt;France;Czech Republic;Canada;Argentina;Brazil;Australia;Netherlands;Germany | ||
| 20 | EUCTR2008-005222-37-GB (EUCTR) | 06/11/2009 | 18/06/2009 | A study with Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 - ENGAGE | Gaucher Disease type I MedDRA version: 14.1;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: eliglustat Other descriptive name: not applicable Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: eliglustat Other descriptive name: not applicable Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: eliglustat Other descriptive name: not applicable | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Saudi Arabia;Lebanon;Russian Federation;Israel;Colombia;United Kingdom;India;Mexico;Canada;Jordan;Bulgaria;Netherlands;Tunisia | ||
| 21 | EUCTR2008-005222-37-NL (EUCTR) | 04/11/2009 | 10/06/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 - ENGAGE | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 - ENGAGE | Gaucher Disease type I MedDRA version: 13.1;Level: PT;Classification code 10018048;Term: Gaucher's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 3 | Bulgaria;Netherlands;United Kingdom | ||
| 22 | EUCTR2008-005223-28-NL (EUCTR) | 04/11/2009 | 01/07/2009 | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached Therapeutic Goals with Enzyme Replacement Therapy - ENCORE | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached Therapeutic Goals with Enzyme Replacement Therapy - ENCORE | Gaucher Disease type I MedDRA version: 9.1;Level: PT;Classification code 10018048;Term: Gaucher's disease | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat Other descriptive name: not available Trade Name: Cerezyme Product Name: Cerezyme Product Code: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: Recombinant human derived macrophage-targeted ß-Glucocerebrosidase | Genzyme Europe B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 186 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;France;Spain;Italy | ||
| 23 | NCT00891202 (ClinicalTrials.gov) | November 2009 | 30/4/2009 | A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease (ENGAGE) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Confirming the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 (ENGAGE) | Gaucher Disease, Type 1 | Drug: Eliglustat tartrate;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Completed | 16 Years | N/A | All | 40 | Phase 3 | United States;Bulgaria;Canada;Colombia;India;Israel;Lebanon;Mexico;Russian Federation;Serbia;Tunisia;United Kingdom;Chile;Georgia;Jordan;Netherlands;Saudi Arabia |
| 24 | EUCTR2008-005223-28-CZ (EUCTR) | 23/09/2009 | 21/08/2009 | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached Therapeutic goals with Enzyme Replacement Therapy - ENCORE | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients with Gaucher Disease Type 1 who have Reached Therapeutic goals with Enzyme Replacement Therapy - ENCORE | Gaucher Disease type I MedDRA version: 9.1;Level: PT;Classification code 10018048;Term: Gaucher's disease | Product Name: Genz-112638 Product Code: Genz-112638 INN or Proposed INN: Eliglustat tartrate Other descriptive name: not available Trade Name: Cerezyme Product Name: Cerezyme Product Code: Imiglucerase INN or Proposed INN: IMIGLUCERASE Other descriptive name: recombinant human derived macrophage-targeted ß-glucocerebrosidase | Genzyme Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Italy;Spain;France;Netherlands;Czech Republic;United Kingdom;Germany | ||
| 25 | NCT00943111 (ClinicalTrials.gov) | September 2009 | 20/7/2009 | A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE) | A Phase 3, Randomized, Multi-Center, Multi-National, Open-Label, Active Comparator Study to Evaluate the Efficacy and Safety of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE) | Gaucher Disease, Type 1 | Drug: Eliglustat tartrate;Drug: Imiglucerase | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Egypt;France;Germany;Italy;Russian Federation;Spain;United Kingdom;Czech Republic;Netherlands;Turkey |
| 26 | NCT00358150 (ClinicalTrials.gov) | June 2006 | 27/7/2006 | A Study of the Efficacy and Safety of Eliglustat Tartrate (Genz-112638) in Type 1 Gaucher Patients | A Phase 2, Open-Label, Multi-Center Study Evaluating the Efficacy, Safety and Pharmacokinetics of Genz-112638 in Gaucher Type 1 Patients | Gaucher Disease, Type 1;Cerebroside Lipidosis Syndrome;Glucocerebrosidase Deficiency Disease;Glucosylceramide Beta-Glucosidase Deficiency Disease;Gaucher Disease, Non-Neuronopathic Form | Drug: Eliglustat tartrate | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 65 Years | All | 26 | Phase 2 | United States;Argentina;Israel;Italy;Mexico;Russian Federation |