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 | EUCTR2011-005400-15-NL (EUCTR) | 24/09/2013 | 04/07/2013 | A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL | Familial Hypercholesterolemia MedDRA version: 18.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: AMG 145 Product Code: AMG 145 Other descriptive name: AMG 145 Product Name: AMG 145 Other descriptive name: AMG145 Product Name: AMG 145 Other descriptive name: AMG145 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Hong Kong;Greece;Spain;Lebanon;Turkey;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Malaysia;Belgium;Brazil;Australia;South Africa;Netherlands;New Zealand;Japan | ||
| 2 | EUCTR2011-005400-15-CZ (EUCTR) | 30/05/2013 | 27/02/2013 | A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL | Familial Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Other descriptive name: AMG 145 Trade Name: Repatha 140 mg solution for injection in pre-filled pen Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Other descriptive name: AMG145 Product Name: Evolocumab Product Code: AMG 145 Other descriptive name: AMG145 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Hong Kong;Greece;Spain;Lebanon;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;South Africa;Netherlands;New Zealand;Japan | ||
| 3 | EUCTR2011-005400-15-GB (EUCTR) | 22/05/2013 | 04/03/2013 | A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL | Familial Hypercholesterolemia MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: AMG 145 Product Code: AMG 145 Other descriptive name: AMG 145 Product Name: AMG 145 Other descriptive name: AMG145 Product Name: AMG 145 Other descriptive name: AMG145 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | South Africa;Netherlands;New Zealand;Japan;Australia;Brazil;Belgium;Malaysia;Canada;Czech Republic;France;United Kingdom;Italy;Israel;Austria;Turkey;Lebanon;Spain;Greece;Hong Kong;United States | ||
| 4 | EUCTR2011-005400-15-BE (EUCTR) | 22/03/2012 | 07/02/2012 | A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations | A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL | Familial Hypercholesterolemia MedDRA version: 20.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: AMG 145 Product Code: AMG 145 Other descriptive name: AMG 145 Product Name: AMG 145 Other descriptive name: AMG145 Product Name: AMG 145 Other descriptive name: AMG145 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Hong Kong;Greece;Spain;Lebanon;Turkey;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Malaysia;Belgium;Brazil;Australia;South Africa;Netherlands;New Zealand;Japan |