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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |
| 7 | 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 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |