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
Showing 1 to 9 of 9 diseases
| 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 | EUCTR2015-002276-25-PT (EUCTR) | 29/07/2019 | 15/11/2018 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Norway;Netherlands;Germany;New Zealand Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Swi ... | ||
| 2 | EUCTR2015-002276-25-SI (EUCTR) | 10/06/2019 | 06/03/2019 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Europe B.V. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Swaziland;Brazil;Belgium;Poland;Germany;Norway United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Switzerland;Mal ... | ||
| 3 | EUCTR2015-002276-25-PL (EUCTR) | 25/01/2019 | 28/03/2019 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Malaysia;Australia;South Africa;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Belgium;Germany;Norway;New Zealand United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Malaysia;Austra ... | ||
| 4 | EUCTR2015-002276-25-NL (EUCTR) | 11/04/2017 | 22/11/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Norway;Netherlands;Germany;New Zealand Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Swi ... | ||
| 5 | EUCTR2015-002276-25-CZ (EUCTR) | 06/10/2016 | 04/05/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;Norway;New Zealand Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada; ... | ||
| 6 | EUCTR2015-002276-25-AT (EUCTR) | 27/06/2016 | 12/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;Norway;New Zealand Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Swi ... | ||
| 7 | EUCTR2015-002276-25-BE (EUCTR) | 23/05/2016 | 13/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Norway;Netherlands;Germany;New Zealand Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Swi ... | ||
| 8 | EUCTR2015-002276-25-NO (EUCTR) | 11/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | South Africa;Netherlands;Norway;Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Germany;New Zealand South Africa;Netherlands;Norway;Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United ... | |||
| 9 | EUCTR2015-002276-25-GB (EUCTR) | 05/04/2016 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg ... | Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH) - HAUSER-OLE Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous f ... | Trade Name: Repatha 140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha 420 mg solution for injection in cartridge Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: EVOLOCUMAB Trade Name: Repatha140 mg Solution for Injection in Pre-filled Pen Product Name: Evolocumab Product Co ... | Amgen Inc | NULL | NA | Female: yes Male: yes | 115 | Phase 3 | Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Norway;Germany;Netherlands;New Zealand Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Ita ... |