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

  
18 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2017-003170-13-AT
(EUCTR)
23/07/201911/02/2019Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
121Phase 3United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
2EUCTR2017-003170-13-IT
(EUCTR)
18/02/201922/01/2021Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial HypercholesterolemiaAn open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia - na Homozygous familial hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850
MedDRA version: 20.0;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: na
Product Name: Evinacumab (REGN1500)
Product Code: [REGN1500]
INN or Proposed INN: Evinacumab
Other descriptive name: Evinacumab
Trade Name: Praluent
Product Name: Praluent
Product Code: [na]
INN or Proposed INN: alirocumab
REGENERON PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3United States;Czechia;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Norway;Germany;Netherlands;Japan
3EUCTR2017-003170-13-GR
(EUCTR)
01/02/201914/01/2019Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
121Phase 3United States;Czechia;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
4EUCTR2017-003170-13-CZ
(EUCTR)
17/12/201811/10/2018Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
121Phase 3United States;Greece;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands;Japan
5EUCTR2017-002297-39-DK
(EUCTR)
03/09/201804/06/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: PT;Classification code 10020603;Term: Hypercholesterolaemia;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Trade Name: Praluent
Product Name: Alirocumab
Product Code: SAR236553
INN or Proposed INN: Alirocumab
Other descriptive name: ALIROCUMAB
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;Taiwan;Slovenia;Spain;Turkey;Austria;Russian Federation;Italy;France;Mexico;Canada;Argentina;Brazil;Denmark;Bulgaria;Netherlands;Norway
6EUCTR2017-001388-19-DE
(EUCTR)
18/06/201823/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
57 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
7EUCTR2017-001388-19-IT
(EUCTR)
11/05/201811/02/2021A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia - - Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Praluent
Product Name: Alirocumab
Product Code: [REGN7272]
INN or Proposed INN: Alirocumab
Other descriptive name: Alirocumab
Product Name: Evinacumab
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: Evinacumab
REGENERON PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Czechia;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
8EUCTR2017-001388-19-GR
(EUCTR)
02/05/201802/04/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
65Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Netherlands;Germany;Japan
9EUCTR2017-001388-19-AT
(EUCTR)
23/03/201830/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
10EUCTR2017-000351-95-DE
(EUCTR)
13/12/201717/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 3France;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
11EUCTR2017-000351-95-GR
(EUCTR)
08/11/201719/10/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH 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]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3Germany;France;United States;Czech Republic;Canada;Greece;Ukraine;Turkey;Austria;South Africa;Italy
12EUCTR2017-000351-95-IT
(EUCTR)
12/10/201709/02/2021A study to the safety and efficacy of Alirocumab in patients with hereditary abnormal (high) cholesterol levelA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the efficacy and safety of Alirocumab in patients with Homozygous Familial Hypercholesterolemia - ODYSSEY HoFH 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]
Trade Name: Praluent
Product Name: R727
Product Code: [R727]
INN or Proposed INN: Alirocumab
Other descriptive name: Alirocumab
REGENERON PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
55Phase 3United States;Czechia;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Denmark;South Africa;Germany
13EUCTR2017-000351-95-AT
(EUCTR)
03/10/201722/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH 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]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
14EUCTR2017-000351-95-FR
(EUCTR)
18/07/201723/06/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH 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]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Italy;France;Denmark;South Africa;Tunisia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
15EUCTR2017-003170-13-FR
(EUCTR)
26/10/2018 Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia An open-label study to evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNA Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Ukraine;Turkey;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Australia;South Africa;Norway;Netherlands;Germany;Japan
16EUCTR2017-001388-19-FR
(EUCTR)
24/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNA Female: yes
Male: yes
57 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
17EUCTR2017-001388-19-CZ
(EUCTR)
01/02/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
18EUCTR2017-000351-95-CZ
(EUCTR)
28/07/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
54Phase 3Serbia;Portugal;United States;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Italy;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Tunisia;Sweden