79. 家族性高コレステロール血症（ホモ接合体） Homozygous familial hypercholesterolemia Clinical trials / Disease details
臨床試験数 : 145 / 薬物数 : 114 - (DrugBank : 26) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 17
| 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 | EUCTR2017-003170-13-AT (EUCTR) | 23/07/2019 | 11/02/2019 | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan | ||
| 2 | EUCTR2017-003170-13-IT (EUCTR) | 18/02/2019 | 22/01/2021 | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia - na | Homozygous familial hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.0;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: na Product Name: Evinacumab (REGN1500) Product Code: [REGN1500] INN or Proposed INN: Evinacumab Other descriptive name: Evinacumab Trade Name: Praluent Product Name: Praluent Product Code: [na] INN or Proposed INN: alirocumab | REGENERON PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | United States;Czechia;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Norway;Germany;Netherlands;Japan | ||
| 3 | EUCTR2017-003170-13-GR (EUCTR) | 01/02/2019 | 14/01/2019 | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | United States;Czechia;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan | ||
| 4 | EUCTR2017-003170-13-CZ (EUCTR) | 17/12/2018 | 11/10/2018 | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan | ||
| 5 | EUCTR2017-002297-39-SI (EUCTR) | 25/09/2018 | 20/06/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway;Netherlands | ||
| 6 | EUCTR2017-002297-39-NO (EUCTR) | 19/09/2018 | 15/05/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Netherlands;United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway | ||
| 7 | EUCTR2017-002297-39-BG (EUCTR) | 11/09/2018 | 31/07/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway | ||
| 8 | EUCTR2017-002297-39-AT (EUCTR) | 04/09/2018 | 07/06/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Austria;United States;Taiwan;Slovenia;Spain;Turkey;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway | ||
| 9 | EUCTR2017-002297-39-DK (EUCTR) | 03/09/2018 | 04/06/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Trade Name: Praluent Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway | ||
| 10 | NCT03510715 (ClinicalTrials.gov) | August 31, 2018 | 18/4/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | Hypercholesterolemia | Drug: Alirocumab SAR236553 (REGN727);Drug: Rosuvastatin;Drug: Ezetimibe;Drug: Cholestyramine;Drug: Nicotinic acid;Drug: Fenofibrate;Drug: Omega-3 fatty acids;Drug: Atorvastatin;Drug: Simvastatin;Drug: Fluvastatin;Drug: Pravastatin;Drug: Lovastatin | Sanofi | Regeneron Pharmaceuticals | Completed | 8 Years | 17 Years | All | 18 | Phase 3 | Brazil;Canada;Denmark;Mexico;Netherlands;Russian Federation;Slovenia;Spain;Taiwan;Turkey;Austria;France;Italy;Norway;United States |
| 11 | EUCTR2017-002297-39-ES (EUCTR) | 28/08/2018 | 09/07/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Bulgaria;Argentina;Russian Federation;United States;Spain;Canada;Austria;Netherlands;Turkey;Norway;Taiwan;Brazil;Denmark;Italy;Mexico;Slovenia;France | ||
| 12 | EUCTR2017-002297-39-FR (EUCTR) | 13/07/2018 | 16/05/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Norway;Netherlands | ||
| 13 | EUCTR2017-002297-39-NL (EUCTR) | 02/07/2018 | 16/05/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway | ||
| 14 | EUCTR2017-002297-39-IT (EUCTR) | 26/06/2018 | 23/05/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB Product Name: Alirocumab Product Code: SAR236553 INN or Proposed INN: Alirocumab Other descriptive name: ALIROCUMAB | Sanofi-Aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway | ||
| 15 | EUCTR2017-001388-19-DE (EUCTR) | 18/06/2018 | 23/01/2018 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands | ||
| 16 | EUCTR2017-001388-19-IT (EUCTR) | 11/05/2018 | 11/02/2021 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia - - | Homozygous familial hypercholesterolemia MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Praluent Product Name: Alirocumab Product Code: [REGN7272] INN or Proposed INN: Alirocumab Other descriptive name: Alirocumab Product Name: Evinacumab Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: Evinacumab | REGENERON PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 3 | United States;Czechia;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands | ||
| 17 | EUCTR2017-001388-19-GR (EUCTR) | 02/05/2018 | 02/04/2018 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Netherlands;Germany;Japan | ||
| 18 | EUCTR2017-001388-19-AT (EUCTR) | 23/03/2018 | 30/01/2018 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 3 | United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands | ||
| 19 | EUCTR2017-000351-95-DE (EUCTR) | 13/12/2017 | 17/08/2017 | A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol level | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH | HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 3 | France;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy | ||
| 20 | EUCTR2017-000351-95-GR (EUCTR) | 08/11/2017 | 19/10/2017 | A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol level | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH | HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Germany;France;United States;Czech Republic;Canada;Greece;Ukraine;Turkey;Austria;South Africa;Italy | ||
| 21 | EUCTR2017-000351-95-IT (EUCTR) | 12/10/2017 | 09/02/2021 | A study to the safety and efficacy of Alirocumab in patients with hereditary abnormal (high) cholesterol level | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the efficacy and safety of Alirocumab in patients with Homozygous Familial Hypercholesterolemia - ODYSSEY HoFH | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent Product Name: R727 Product Code: [R727] INN or Proposed INN: Alirocumab Other descriptive name: Alirocumab | REGENERON PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | United States;Czechia;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Denmark;South Africa;Germany | ||
| 22 | NCT03156621 (ClinicalTrials.gov) | October 3, 2017 | 15/5/2017 | Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia | Drug: Alirocumab;Drug: Placebo | Regeneron Pharmaceuticals | Sanofi | Completed | 18 Years | N/A | All | 69 | Phase 3 | United States;Austria;Canada;Czechia;France;Germany;Greece;Italy;Japan;South Africa;Taiwan;Turkey;Ukraine |
| 23 | EUCTR2017-000351-95-AT (EUCTR) | 03/10/2017 | 22/08/2017 | A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol level | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH | HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | Greece;Canada;Austria;Czech Republic;Turkey;United States;Ukraine;Italy;South Africa;France;Germany | ||
| 24 | EUCTR2017-000351-95-FR (EUCTR) | 18/07/2017 | 23/06/2017 | A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol level | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH | HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 54 | Phase 3 | United States;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Italy;France;Denmark;South Africa;Tunisia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 25 | EUCTR2017-001388-19-FR (EUCTR) | 24/01/2018 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands | |||
| 26 | EUCTR2017-003170-13-FR (EUCTR) | 26/10/2018 | Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Ukraine;Turkey;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Norway;Netherlands;Germany;Japan | |||
| 27 | EUCTR2017-000351-95-CZ (EUCTR) | 28/07/2017 | A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol level | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH | HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 54 | Phase 3 | Serbia;Portugal;United States;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Italy;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Tunisia;Sweden | |||
| 28 | EUCTR2017-001388-19-CZ (EUCTR) | 01/02/2018 | A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol level | A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia | Homozygous familial hypercholesterolemia MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Evinacumab (REGN1500) Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB Trade Name: Praluent INN or Proposed INN: ALIROCUMAB Other descriptive name: ALIROCUMAB | Regeneron Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Phase 3 | United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands |