LIB003 ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 79 | 家族性高コレステロール血症（ホモ接合体） | 4 |
79. 家族性高コレステロール血症（ホモ接合体）
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
| 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 | EUCTR2020-004394-49-ES (EUCTR) | 31/03/2022 | 02/02/2022 | Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease. | Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE) - LIBerate-OLE | Patients with elevated LDL-C, with homozygous familial hypercholesterolemia (HoFH) and heterozygous familialhypercholesterolemia (HeFH), cardiovascular disease, or at high risk for cardiovascular disease. MedDRA version: 20.0;Level: LLT;Classification code 10057079;Term: Heterozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10007648;Term: Cardiovascular disease, unspecified;System Organ Class: 100000004849;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: LIB003 Product Code: lerodalcibep INN or Proposed INN: Lerodalcibep Other descriptive name: LIB003 | LIB Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 3 | United States;France;Canada;Spain;Turkey;South Africa;Israel;Norway;Germany;United Kingdom;New Zealand;India | ||
| 2 | EUCTR2020-004394-49-NO (EUCTR) | 12/08/2021 | 25/05/2021 | Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease. | Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE) - LIBerate-OLE | Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease MedDRA version: 20.0;Level: LLT;Classification code 10057079;Term: Heterozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10007648;Term: Cardiovascular disease, unspecified;System Organ Class: 100000004849;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: LIB003 Product Code: lerodalcibep INN or Proposed INN: Lerodalcibep Other descriptive name: LIB003 | LIB Therapeutics, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2350 | Phase 3 | France;United States;Canada;Spain;Turkey;South Africa;Israel;Germany;Norway;United Kingdom;New Zealand;India | ||
| 3 | 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, 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 | 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] | Product Code: LIB003 INN or Proposed INN: not available Other descriptive name: LIB003 Trade Name: Repatha (evolocumab) INN or Proposed INN: EVOLOCUMAB | 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 | ||
| 4 | EUCTR2020-004394-49-DE (EUCTR) | 27/05/2021 | Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease. | Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE) - LIBerate-OLE | Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease MedDRA version: 20.0;Level: LLT;Classification code 10057079;Term: Heterozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10007648;Term: Cardiovascular disease, unspecified;System Organ Class: 100000004849;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: LIB003 Product Code: lerodalcibep INN or Proposed INN: Lerodalcibep Other descriptive name: LIB003 | LIB Therapeutics, LLC | NULL | NA | Female: yes Male: yes | 2000 | Phase 3 | United States;France;Canada;Spain;Turkey;South Africa;Israel;Norway;Germany;United Kingdom;New Zealand;India |