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
| 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-IT (EUCTR) | 25/07/2016 | 15/06/2021 | Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial Hypercholesterolemia | 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) - Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozyg | 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] | Trade Name: Repatha 140 mg soluzione per iniezione in penna preriempita. Product Name: Evolocumab Product Code: AMG 145 INN or Proposed INN: Evolocumab Trade Name: Repatha 420 mg soluzione per iniezione in cartuccia Product Name: Evolocumab Product Code: [AMG 145] INN or Proposed INN: EVOLOCUMAB | 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 |