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 10 of 21 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 | EUCTR2019-003611-62-NO (EUCTR) | 20/03/2020 | 28/11/2019 | Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumabto Evaluat ... | Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. - LIB003-003 Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with ... | Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Homozygous Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 1005708 ... | Product Code: LIB003 INN or Proposed INN: not available Other descriptive name: LIB003 Trade Name: Repatha (evolocumab) INN or Proposed INN: EVOLOCUMAB Product Code: LIB003 INN or Proposed INN: not available Other descriptive name: LIB003 Trade Name: Repa ... | LIB Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Turkey;Israel;South Africa;Norway | ||
| 2 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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 ... | ||
| 3 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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 ... | ||
| 4 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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 ... | ||
| 5 | NCT03403374 (ClinicalTrials.gov) | August 4, 2018 | 3/1/2018 | Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hyp ... | A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patie ... | Homozygous Familial Hypercholesterolemia HoFH | Drug: evolocumab | Amgen | NULL | Completed | 12 Years | 80 Years | All | 30 | Phase 4 | India |
| 6 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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 ... | ||
| 7 | EUCTR2015-002276-25-ES (EUCTR) | 27/02/2017 | 05/08/2016 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 19.0;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 19.0;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: 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;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;Norway;New Zealand Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;C ... | ||
| 8 | EUCTR2015-002276-25-DE (EUCTR) | 21/10/2016 | 05/04/2016 | 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) Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | 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) Open-label, Single-arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Hypercholesterolemia MedDRA version: 18.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 MedDRA version: 18.1;Classification code 10057099;Term: Heterozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Hypercholesterolemia MedDRA version: 18.1;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: 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;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;Italy;United Kingdom;Czech Republic;Hungary;C ... | ||
| 9 | 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 evolocumabin children aged 10 to 17 years with Heterozygo ... | 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; ... | ||
| 10 | NCT02624869 (ClinicalTrials.gov) | September 10, 2016 | 22/10/2015 | Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab(AMG 145) in Pediatric S ... | 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) Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolo ... | Familial Hypercholesterolemia | Biological: evolocumab (AMG 145) | Amgen | NULL | Completed | 10 Years | 17 Years | All | 163 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Czechia;Greece;Hungary;Italy;Malaysia;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovenia;South Africa;Spain;Switzerland;Turkey;United Kingdom United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Czechia;Greece;Hungary;Italy;Malaysia ... |