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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-003998-28-NL (EUCTR) | 28/02/2012 | 14/11/2011 | Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemia | Modifying 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 Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;United States;Canada;Netherlands;Italy;United Kingdom | |||
| 2 | EUCTR2011-003998-28-IT (EUCTR) | 16/02/2012 | 08/03/2012 | Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemia | Modifying 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 30 | United States;Canada;Netherlands;United Kingdom;Italy | |||
| 3 | EUCTR2011-003998-28-GB (EUCTR) | 24/01/2012 | 19/10/2011 | Effect of CER-001 on blockage of arteries (plaque) in subjects with homozygous familial hypercholesterolemia | Modifying 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 Therapeutics | NULL | Not 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): no | United States;Canada;Netherlands;Italy;United Kingdom | ||
| 4 | NCT01412034 (ClinicalTrials.gov) | November 2011 | 5/8/2011 | Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects | Modifying 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 Hypercholesterolemia | Drug: CER-001 | Cerenis Therapeutics, SA | NULL | Completed | 12 Years | N/A | Both | 23 | Phase 2 | United States;Canada;Italy;Netherlands;United Kingdom |