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 | NCT03933293 (ClinicalTrials.gov) | May 13, 2019 | 28/4/2019 | A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH | A Phase 2 Study to Evaluate the Safety and Efficacy of PCSK9 Inhibitor AK102 in Patients With Homozygous Familial Hypercholesterolemia (HoFH) | Homozygous Familial Hypercholesterolemia | Drug: AK102;Drug: Statins;Drug: Ezetimibe | Akeso | AD Pharmaceuticals Co., Ltd. | Completed | 18 Years | N/A | All | 10 | Phase 2 | China |
| 2 | NCT03510715 (ClinicalTrials.gov) | August 31, 2018 | 18/4/2018 | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | An Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia | Hypercholesterolemia | Drug: Alirocumab SAR236553 (REGN727);Drug: Rosuvastatin;Drug: Ezetimibe;Drug: Cholestyramine;Drug: Nicotinic acid;Drug: Fenofibrate;Drug: Omega-3 fatty acids;Drug: Atorvastatin;Drug: Simvastatin;Drug: Fluvastatin;Drug: Pravastatin;Drug: Lovastatin | Sanofi | Regeneron Pharmaceuticals | Completed | 8 Years | 17 Years | All | 18 | Phase 3 | Brazil;Canada;Denmark;Mexico;Netherlands;Russian Federation;Slovenia;Spain;Taiwan;Turkey;Austria;France;Italy;Norway;United States |
| 3 | NCT00704535 (ClinicalTrials.gov) | March 2006 | 23/6/2008 | Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED) | Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients | Primary Hypercholesterolemia;Homozygous Familial Hypercholesterolemia | Drug: Ezetimibe | Organon and Co | NULL | Completed | 18 Years | N/A | All | 4105 | Philippines | |
| 4 | NCT00092833 (ClinicalTrials.gov) | July 2002 | 23/9/2004 | Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED) | An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia | Hypercholesterolemia, Familial;Lipid Metabolism, Inborn Errors | Drug: Comparator: ezetimibe | Organon and Co | NULL | Terminated | 8 Years | N/A | All | 49 | Phase 3 | United States |
| 5 | NCT03885921 (ClinicalTrials.gov) | October 25, 2000 | 20/3/2019 | Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019) | Long-Term, Open-Label, Safety and Tolerability Study of SCH 58235 in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia | Hypercholesterolemia | Drug: Ezetimibe;Drug: Atorvastatin;Drug: Simvastatin | Organon and Co | NULL | Completed | 12 Years | N/A | All | 44 | Phase 3 | NULL |
| 6 | NCT03884452 (ClinicalTrials.gov) | May 3, 2000 | 6/3/2019 | Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018) | A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial Hypercholesterolemia | Familial Hypercholesterolemia | Drug: Atorvastatin;Drug: Simvastatin;Drug: Ezetimibe;Drug: Placebo for Ezetimibe | Organon and Co | NULL | Completed | 12 Years | N/A | All | 50 | Phase 3 | NULL |