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 : 142 / 薬物数 : 114 - (DrugBank : 29) / 標的遺伝子数 : 9 - 標的パスウェイ数 : 18
| 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 | EUCTR2019-001931-30-NL (EUCTR) | 03/11/2020 | 30/07/2020 | A trial to evaluate the Efficacy and Safety of Evinacumab in Paediatric Patients With Homozygous Familial Hypercholesterolemia | A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric 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 Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 1;Phase 3 | United States;Taiwan;Ukraine;Lebanon;Austria;Italy;France;Canada;Jordan;Belgium;Australia;Netherlands;Germany;Norway | ||
| 2 | EUCTR2019-001931-30-AT (EUCTR) | 17/08/2020 | 03/03/2020 | A trial to evaluate the Efficacy and Safety of Evinacumab in Paediatric Patients With Homozygous Familial Hypercholesterolemia | A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric 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 Product Code: REGN1500 INN or Proposed INN: Evinacumab Other descriptive name: EVINACUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 1;Phase 3 | Australia;Germany;Netherlands;Norway;Belgium;Jordan;Canada;France;Italy;Austria;Lebanon;Ukraine;Taiwan;United States | ||
| 3 | NCT04233918 (ClinicalTrials.gov) | June 29, 2020 | 6/1/2020 | Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia | A Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia | Homozygous Familial Hypercholesterolemia | Drug: Evinacumab | Regeneron Pharmaceuticals | NULL | Active, not recruiting | 5 Years | 11 Years | All | 20 | Phase 3 | United States;Australia;Austria;Netherlands;Taiwan;Ukraine |
| 4 | 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 | ||
| 5 | EUCTR2017-003170-13-GB (EUCTR) | 12/03/2019 | 21/01/2019 | 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: 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 | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | JPRN-JapicCTI-184099 | 30/9/2018 | 20/08/2018 | STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | 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 (HoFH) | Intervention name : Evinacumab INN of the intervention : Evinacumab Dosage And administration of the intervention : INTRAVENOUS Injection Control intervention name : PLACEBO INN of the control intervention : - Dosage And administration of the control intervention : INTRAVENOUS Injection | Regeneron Pharmaceuticals, Inc.(ICCC: PAREXEL International) | NULL | complete | 18 | BOTH | 57 | NA | Japan, North America, Europe, Oceania, Africa | |
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | EUCTR2017-003170-13-NL (EUCTR) | 15/03/2018 | 10/01/2018 | 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 | 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;Netherlands;Germany;Japan | ||
| 15 | NCT03409744 (ClinicalTrials.gov) | March 13, 2018 | 8/1/2018 | 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 | Drug: evinacumab | Regeneron Pharmaceuticals | NULL | Active, not recruiting | 12 Years | N/A | All | 116 | Phase 3 | United States;Australia;Austria;Canada;Czechia;France;Greece;Italy;Japan;Netherlands;South Africa;Ukraine;Norway |
| 16 | NCT03399786 (ClinicalTrials.gov) | January 18, 2018 | 8/1/2018 | Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia | 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 | Drug: evinacumab;Drug: Placebo | Regeneron Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 65 | Phase 3 | United States;Australia;Austria;Canada;France;Greece;Italy;Japan;Netherlands;South Africa;Ukraine;Czechia;Germany;Turkey |
| 17 | EUCTR2016-000411-32-NL (EUCTR) | 15/07/2016 | 17/05/2016 | A study to the safety and efficacy of REGN1500 in patients with Hereditary abnormal (high) cholesterol level | AN OPEN-LABEL, SINGLE-ARM, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE DOSES OF REGN1500 IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | Homozygous Familial Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: evinacumab Product Code: REGN1500 INN or Proposed INN: EVINACUMAB Other descriptive name: EVINACUMAB Product Name: Evinacumab Product Code: REGN1500 INN or Proposed INN: EVINACUMAB Other descriptive name: EVINACUMAB 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 | 8 | Phase 2 | United States;Canada;Netherlands | ||
| 18 | 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 | |||
| 19 | 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 | |||
| 20 | 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 |