Evolocumab    (DrugBank: Evolocumab)

2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
79家族性高コレステロール血症(ホモ接合体)20
222一次性ネフローゼ症候群1

79. 家族性高コレステロール血症(ホモ接合体) [臨床試験数:128,薬物数:105(DrugBank:29),標的遺伝子数:8,標的パスウェイ数:15
Searched query = "Homozygous familial hypercholesterolemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
20 / 128 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003611-62-NO
(EUCTR)
20/03/202028/11/2019Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy. - LIB003-003 Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: LIB003
INN or Proposed INN: not available
Other descriptive name: LIB003
Trade Name: Repatha (evolocumab)
INN or Proposed INN: EVOLOCUMAB
LIB Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Turkey;Israel;South Africa;Norway
2NCT04034485
(ClinicalTrials.gov)
November 7, 201922/7/2019Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFHRandomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering TherapyHomozygous Familial HypercholesterolemiaDrug: LIB003;Drug: evolocumabLIB Therapeutics LLCNULLEnrolling by invitation10 YearsN/AAll70Phase 3United States;Israel;Norway;South Africa;Turkey
3EUCTR2015-002276-25-PT
(EUCTR)
29/07/201915/11/2018Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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]
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
115 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Malaysia;Australia;South Africa;Netherlands;Germany;New Zealand
4EUCTR2015-002276-25-SI
(EUCTR)
10/06/201906/03/2019Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
Trade Name: Repatha 420 mg solution for injection in cartridge
Product Name: Evolocumab
Product Code: AMG 145
Amgen Europe B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Portugal;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Swaziland;Brazil;Belgium;Poland;Germany;Norway
5EUCTR2015-002276-25-PL
(EUCTR)
25/01/201928/03/2019Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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]
Amgen IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
115 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Brazil;Malaysia;Australia;South Africa;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03403374
(ClinicalTrials.gov)
August 4, 20183/1/2018Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial HypercholesterolemiaA Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in IndiaHomozygous Familial Hypercholesterolemia HoFHDrug: evolocumabAmgenNULLCompleted12 Years80 YearsAll30Phase 4India
7EUCTR2015-002276-25-NL
(EUCTR)
11/04/201722/11/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE Hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850
MedDRA version: 19.0;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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3Greece;Turkey;Austria;Colombia;Hungary;Czech Republic;Canada;Brazil;Australia;South Africa;Netherlands;Germany;New Zealand
8EUCTR2015-002276-25-ES
(EUCTR)
27/02/201705/08/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE Hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850
MedDRA version: 19.0;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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3Greece;Spain;Turkey;Austria;Colombia;Hungary;Czech Republic;Canada;Brazil;Australia;South Africa;Netherlands;Germany;New Zealand
9EUCTR2015-002276-25-DE
(EUCTR)
21/10/201605/04/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) Hypercholesterolemia
MedDRA version: 18.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850
MedDRA version: 18.1;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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
115Phase 3Czech Republic;Hungary;Greece;Canada;Brazil;Turkey;Austria;Australia;South Africa;Colombia;Germany;New Zealand
10EUCTR2015-002276-25-CZ
(EUCTR)
06/10/201604/05/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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]
Amgen IncNULLNot Recruiting Female: yes
Male: yes
115 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02624869
(ClinicalTrials.gov)
September 10, 201622/10/2015Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH).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)Familial HypercholesterolemiaBiological: evolocumab (AMG 145)AmgenNULLActive, not recruiting10 Years17 YearsAll163Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Czechia;Greece;Hungary;Italy;Malaysia;Netherlands;Norway;Poland;Portugal;Russian Federation;Slovenia;South Africa;Spain;Switzerland;Turkey;United Kingdom
12EUCTR2015-002276-25-AT
(EUCTR)
27/06/201612/04/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Trade Name: Repatha 420 mg solution for injection in cartridge
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
115Phase 3Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Germany;Netherlands;Norway;New Zealand
13EUCTR2015-002276-25-HU
(EUCTR)
06/06/201612/04/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE Hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850
MedDRA version: 19.0;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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3Hungary;Greece;Canada;Brazil;Turkey;Australia;South Africa;Colombia;New Zealand
14JPRN-UMIN000022603
2016/06/0604/06/2016Non-randomized, prospective, non-controlled study of changes of lipid parameters after introduction of evolocumab in patients with heterozygous familial hypercholesterolemia under LDL-apheresis therapy. Homozygous familial hypercholesterolemiaSubcutaneous injection of evolocumabKanazawa University HospitalNULLComplete: follow-up complete20years-old100years-oldMale and Female2Not selectedJapan
15EUCTR2015-002276-25-GR
(EUCTR)
01/06/201616/05/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3Portugal;Slovenia;Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-002276-25-BE
(EUCTR)
23/05/201613/04/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Trade Name: Repatha 420 mg solution for injection in cartridge
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3Greece;Spain;Turkey;Austria;Colombia;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;South Africa;Netherlands;Germany;New Zealand
17EUCTR2011-005400-15-CZ
(EUCTR)
30/05/201327/02/2013A clinical study to assess the safety and efficacy of AMG 145 on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutationsA Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 145 on LDL-C in Subjects With Severe Familial Hypercholesterolemia - TAUSSIG - Trial Assessing long term USe of PCSK9 Inhibition in Subjects wIth Genetic LDL Familial Hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: evolocumab
Product Code: AMG 145
INN or Proposed INN: Evolocumab
Other descriptive name: AMG 145
Trade Name: Repatha 140 mg solution for injection in pre-filled pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: Evolocumab
Other descriptive name: AMG145
Product Name: Evolocumab
Product Code: AMG 145
Other descriptive name: AMG145
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
300Phase 2;Phase 3United States;Hong Kong;Greece;Spain;Lebanon;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;South Africa;Netherlands;New Zealand;Japan
18NCT01588496
(ClinicalTrials.gov)
April 5, 201227/2/2012Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaBiological: Evolocumab;Drug: PlaceboAmgenNULLCompleted12 Years80 YearsAll58Phase 2/Phase 3United States;Belgium;Canada;Czechia;France;Hong Kong;Italy;Lebanon;Netherlands;New Zealand;South Africa;Spain;Czech Republic
19EUCTR2011-005399-40-Outside-EU/EEA
(EUCTR)
17/12/2014A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia - TESLA Homozygous familial hypercholesterolaemia
MedDRA version: 17.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLNAFemale: yes
Male: yes
59Phase 2/3South Africa;Turkey;United States;Brazil;Canada;Hong Kong;Lebanon;Malaysia;New Zealand
20EUCTR2015-002276-25-GB
(EUCTR)
05/04/2016Study to assess the safety and efficacy of evolocumab in children aged 10 to 17 years with Heterozygous Familial Hypercholesterolemia or Homozygous Familial HypercholesterolemiaOpen-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) - HAUSER-OLE 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 Solution for Injection in Pre-filled Pen
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Trade Name: Repatha 420 mg solution for injection in cartridge
Product Name: Evolocumab
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLNAFemale: yes
Male: yes
115Phase 3Portugal;Czechia;Slovenia;Greece;Spain;Turkey;Austria;Russian Federation;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;South Africa;Norway;Germany;Netherlands;New Zealand

222. 一次性ネフローゼ症候群 [臨床試験数:234,薬物数:241(DrugBank:78),標的遺伝子数:59,標的パスウェイ数:185
Searched query = "Primary nephrotic syndrome", "Minimal change nephrotic syndrome", "MCNS", "Membranous nephropathy", "Focal segmental glomerulosclerosis", "FSGS", "Membranoproliferative glomerulonephritis", "MPGN"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 234 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000038242
2019/10/0109/10/2019The effect of Evolocumab on primary nephrotic syndromeThe effect of Evolocumab on primary nephrotic syndrome - The effect of Evolocumab on primary nephrotic syndrome Primary nephrotic syndromeEvolocumabDepartment of Nephrology, Nippon Medical SchoolNULLRecruiting16years-oldNot applicableMale and Female10Not selectedJapan