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

  
8 trials found
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1EUCTR2020-002755-38-NL
(EUCTR)
23/02/202126/12/2020Study to evaluate efficacy and safety of inclisiran in adolescents with homozygous familial hypercholesterolemiaTwo part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13) Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: inclisiran sodium
Product Code: KJX839
INN or Proposed INN: inclisiran
Other descriptive name: Inclisiran sodium
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 3France;United States;Serbia;Slovenia;Greece;Canada;Lebanon;Turkey;Netherlands;Switzerland
2NCT04659863
(ClinicalTrials.gov)
February 16, 20212/12/2020Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial HypercholesterolemiaTwo Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)Familial Hypercholesterolemia - HomozygousDrug: Inclisiran;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting12 Years17 YearsAll12Phase 3United States;Canada;France;Greece;Lebanon;Netherlands;Slovenia;Switzerland;Turkey
3EUCTR2020-002755-38-GR
(EUCTR)
02/02/202113/12/2020Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13) Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13) Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: inclisiran sodium
Product Code: KJX839
INN or Proposed INN: inclisiran
Other descriptive name: Inclisiran sodium
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 3France;United States;Serbia;Slovenia;Canada;Greece;Lebanon;Turkey;Netherlands;Switzerland
4EUCTR2020-002755-38-SI
(EUCTR)
30/12/202002/12/2020Study to evaluate efficacy and safety of inclisiran in adolescents with homozygous familial hypercholesterolemiaTwo part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13) Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: inclisiran sodium
Product Code: KJX839
INN or Proposed INN: inclisiran
Other descriptive name: Inclisiran sodium
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 3Serbia;United States;Slovenia;Greece;Lebanon;Turkey;Italy;Switzerland;France;Canada;South Africa;Germany;Netherlands
5NCT03814187
(ClinicalTrials.gov)
April 16, 201917/1/2019Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-CAn Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-CASCVD;Elevated Cholesterol;Heterozygous Familial Hypercholesterolemia;Homozygous Familial HypercholesterolemiaDrug: Inclisiran SodiumNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll3275Phase 3United States;Canada;Czechia;Denmark;Germany;Hungary;Netherlands;Poland;South Africa;Spain;Sweden;Ukraine;United Kingdom
6NCT03851705
(ClinicalTrials.gov)
February 6, 20197/2/2019A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5)Homozygous Familial HypercholesterolemiaDrug: Inclisiran for injection;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years80 YearsAll56Phase 3Hong Kong;Israel;Russian Federation;Serbia;South Africa;Taiwan;Turkey;Ukraine;Czechia
7EUCTR2016-003376-49-NL
(EUCTR)
20/06/201718/01/2017A study to evaluate the effect of ALN-PCSSC treatment in patients with Homozygous Familial HypercholesterolemiaAn Open-Label, Single-Arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of ALN-PCSSC in Subjects with Homozygous Familial Hypercholesterolemia - ORION-2 Homozygous Familial Hypercholesterolemia
MedDRA version: 19.1;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ALN-PCSSC
Product Code: ALN-PCSSC
INN or Proposed INN: ALN-60212
Other descriptive name: ALN-60212
The Medicines CompanyNULLNot RecruitingFemale: yes
Male: yes
10Phase 2United States;South Africa;Netherlands
8NCT02963311
(ClinicalTrials.gov)
December 13, 201610/11/2016A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)An Open-Label, Single-Arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of ALN-PCSSC in Subjects With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial HypercholesterolemiaDrug: ALN-PCSSC;Drug: Standard of CareThe Medicines CompanyNULLCompleted12 YearsN/AAll9Phase 2United States;Netherlands;South Africa