Repatha 140 mg solution for injection in pre-filled pen    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
79Homozygous familial hypercholesterolemia10

79. Homozygous familial hypercholesterolemia    [ 128 clinical trials,   105 drugs,   (DrugBank: 29 drugs),   8 drug target genes,   15 drug target pathways]
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.
10 / 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
1EUCTR2015-002276-25-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
2EUCTR2015-002276-25-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
3EUCTR2015-002276-25-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
4EUCTR2015-002276-25-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
5EUCTR2015-002276-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2015-002276-25-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
7EUCTR2015-002276-25-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
8EUCTR2015-002276-25-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
9EUCTR2011-005400-15-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
10EUCTR2015-002276-25-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