CER-001 ( DrugBank: - )


1 disease
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)4

79. 家族性高コレステロール血症(ホモ接合体)


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
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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PhaseCountries
1EUCTR2011-003998-28-NL
(EUCTR)
28/02/201214/11/2011Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemiaModifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-Label Study of the Effects of CER-001 on Plaque Volume in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - MODE homozygous familial hypercholesterolemia
MedDRA version: 16.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Recombinant Human Apolipoprotein A-I/Phospholipids Complex
Product Code: CER-001
Other descriptive name: recombinant human apolipoprotein A-I
Other descriptive name: sphingomyelin
Other descriptive name: 1,2-Dihexadecanoyl-sn-Glycero-3-Phospho-(1-raac-glycerol)
Cerenis TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
30France;United States;Canada;Netherlands;Italy;United Kingdom
2EUCTR2011-003998-28-IT
(EUCTR)
16/02/201208/03/2012Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemiaModifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-Label Study of the Effects of CER-001 on Plaque Volume in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - MODE Homozygous familial hypercholesterolemia
MedDRA version: 15.1;Level: SOC;Classification code 10027433;Term: Metabolism and nutrition disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Recombinant Human Apolipoprotein
Product Code: CER-001
Other descriptive name: Recombinant Human Apolipoprotein A-I
Other descriptive name: Sfingomielina
Other descriptive name: 1,2-Dihexadecanoyl-sn-Glycero-3-Phospho-(1-raac-glycerol)
CERENIS THERAPEUTICS SANULLNot RecruitingFemale: yes
Male: yes
30United States;Canada;Netherlands;United Kingdom;Italy
3EUCTR2011-003998-28-GB
(EUCTR)
24/01/201219/10/2011Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemiaModifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-Label Study of the Effects of CER-001 on Plaque Volume in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - MODE homozygous familial hypercholesterolemia
MedDRA version: 15.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Recombinant Human Apolipoprotein A-I/Phospholipids Complex
Product Code: CER-001
INN or Proposed INN: recombinant human apolipoprotein a1
Other descriptive name: recombinant human apolipoprotein A-I
INN or Proposed INN: sphingomyelin
Other descriptive name: sphingomyelin
INN or Proposed INN: DPPG
Other descriptive name: 1,2-Dihexadecanoyl-sn-Glycero-3-Phospho-(1-raac-glycerol)
Cerenis TherapeuticsNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Netherlands;Italy;United Kingdom
4NCT01412034
(ClinicalTrials.gov)
November 20115/8/2011Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) SubjectsModifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-label Study of the Effects of CER-001 on Plaque Volume in Subjects With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial HypercholesterolemiaDrug: CER-001Cerenis Therapeutics, SANULLCompleted12 YearsN/ABoth23Phase 2United States;Canada;Italy;Netherlands;United Kingdom