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

  
21 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05611528
(ClinicalTrials.gov)
February 21, 202331/10/2022Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial HypercholesterolemiaSafety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia in a Real Life Setting in CanadaHomozygous Familial HypercholesterolemiaDrug: EvinacumabDaniel GaudetUltragenyx Pharmaceutical IncRecruiting18 YearsN/AAll10Phase 3Canada
2EUCTR2019-001931-30-NL
(EUCTR)
03/11/202030/07/2020A trial to evaluate the Efficacy and Safety of Evinacumab in Paediatric Patients With Homozygous Familial HypercholesterolemiaA Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric 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
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28Phase 1;Phase 3United States;Taiwan;Ukraine;Lebanon;Austria;Italy;France;Canada;Jordan;Belgium;Australia;Netherlands;Germany;Norway
3EUCTR2019-001931-30-AT
(EUCTR)
17/08/202003/03/2020A trial to evaluate the Efficacy and Safety of Evinacumab in Paediatric Patients With Homozygous Familial HypercholesterolemiaA Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric 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
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 3United States;Taiwan;Australia;Austria;Netherlands
4NCT04233918
(ClinicalTrials.gov)
June 29, 20206/1/2020Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial HypercholesterolemiaA Three-Part, Single-Arm, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Evinacumab in Pediatric Patients With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: EvinacumabRegeneron PharmaceuticalsNULLActive, not recruiting5 Years11 YearsAll20Phase 3United States;Australia;Austria;Netherlands;Taiwan;Ukraine
5EUCTR2017-003170-13-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
6EUCTR2017-003170-13-GB
(EUCTR)
12/03/201921/01/2019 Evaluate 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 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
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished 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
7EUCTR2017-003170-13-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
8EUCTR2017-003170-13-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
9EUCTR2017-003170-13-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
10JPRN-JapicCTI-184099
30/9/201820/08/2018STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIAA 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 (HoFH)Intervention name : Evinacumab
INN of the intervention : Evinacumab
Dosage And administration of the intervention : INTRAVENOUS Injection
Control intervention name : PLACEBO
INN of the control intervention : -
Dosage And administration of the control intervention : INTRAVENOUS Injection
Regeneron Pharmaceuticals, Inc.(ICCC: PAREXEL International)NULLcomplete18BOTH57NAJapan, North America, Europe, Oceania, Africa
11EUCTR2017-001388-19-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
12EUCTR2017-001388-19-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
13EUCTR2017-001388-19-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
14EUCTR2017-001388-19-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
15EUCTR2017-003170-13-NL
(EUCTR)
15/03/201810/01/2018Evaluate 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
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
121Phase 3United States;Japan;Ukraine;United Kingdom;Greece;Canada;Netherlands;Austria;Czech Republic;Italy;South Africa;Australia;France;Germany
16NCT03409744
(ClinicalTrials.gov)
March 13, 20188/1/2018Evaluate 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 HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: evinacumabRegeneron PharmaceuticalsNULLActive, not recruiting12 YearsN/AAll116Phase 3United States;Australia;Austria;Canada;Czechia;France;Greece;Italy;Japan;Netherlands;South Africa;Ukraine;Norway
17NCT03399786
(ClinicalTrials.gov)
January 18, 20188/1/2018Efficacy and Safety of Evinacumab in Patients With Homozygous Familial HypercholesterolemiaA Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: evinacumab;Drug: PlaceboRegeneron PharmaceuticalsNULLCompleted12 YearsN/AAll65Phase 3United States;Australia;Austria;Canada;France;Greece;Italy;Japan;Netherlands;South Africa;Ukraine;Czechia;Germany;Turkey
18EUCTR2016-000411-32-NL
(EUCTR)
15/07/201617/05/2016A study to the safety and efficacy of REGN1500 in patients with Hereditary abnormal (high) cholesterol levelAN OPEN-LABEL, SINGLE-ARM, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE DOSES OF REGN1500 IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Homozygous Familial Hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: evinacumab
Product Code: REGN1500
INN or Proposed INN: EVINACUMAB
Other descriptive name: EVINACUMAB
Product Name: Evinacumab
Product Code: REGN1500
INN or Proposed INN: EVINACUMAB
Other descriptive name: EVINACUMAB
Product Name: evinacumab
Product Code: REGN1500
INN or Proposed INN: EVINACUMAB
Other descriptive name: EVINACUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
8Phase 2United States;Canada;Netherlands
19EUCTR2017-003170-13-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
20EUCTR2017-001388-19-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
21EUCTR2017-001388-19-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