Anti-C5 antibody ( DrugBank: - )
4 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 11 | 重症筋無力症 | 1 |
| 14 | 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー | 1 |
| 62 | 発作性夜間ヘモグロビン尿症 | 23 |
| 109 | 非典型溶血性尿毒症症候群 | 34 |
11. 重症筋無力症
臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
| 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 | EUCTR2009-014669-13-GB (EUCTR) | 29/12/2009 | 23/10/2009 | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 | Generalized Myasthenia Gravis (gMG) MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis | Trade Name: SOLIRIS Product Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | Alexion Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | United Kingdom |
14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー
臨床試験数 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | EUCTR2008-005748-18-GB (EUCTR) | 02/01/2009 | 12/12/2008 | SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY | SAFETY AND TOLERABILITY OF ECULIZUMAB IN THE TREATMENT OF MULTIFOCAL MOTOR NEUROPATHY: AN OPEN LABEL STUDY | Multifocal motor neuropathy MedDRA version: 9.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | Greater Glasgow and Clyde NHS Board and The University Of Glasgow | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 292 / 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
| 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 | NCT05630001 (ClinicalTrials.gov) | May 30, 2023 | 18/11/2022 | This is a Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan. | A Multicenter, Single Arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Have Hb=10 g/dL in Response to Anti-C5 Antibody and Switch to Iptacopan | Paroxysmal Nocturnal Hemoglobinuria | Drug: Iptacopan | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | N/A | All | 50 | Phase 3 | NULL |
| 2 | EUCTR2019-004665-40-CZ (EUCTR) | 31/03/2021 | 03/11/2020 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of | ||
| 3 | JPRN-jRCT2051200132 | 26/03/2021 | 09/02/2021 | Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment | Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment - APPLY-PNH | Paroxysmal nocturnal hemoglobinuria PNH | Arm A : LNP023 monotherapy Arm B : Anti-C5 antibody treatment(Eculizumab or Ravulizumab) | Suzuki Kazuyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 91 | Phase 3 | Netherlands;Japan |
| 4 | EUCTR2019-004665-40-DE (EUCTR) | 29/01/2021 | 22/09/2020 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris 300mg/30ml Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris 300mg/30ml Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of | ||
| 5 | NCT04558918 (ClinicalTrials.gov) | January 25, 2021 | 27/8/2020 | Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment | A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody. | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: LNP023;Drug: Eculizumab;Drug: Ravulizumab | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 97 | Phase 3 | United States;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Taiwan;United Kingdom;Hungary |
| 6 | EUCTR2019-004665-40-IT (EUCTR) | 23/12/2020 | 15/06/2021 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody - Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: Iptacopan Product Code: [LNP023] INN or Proposed INN: Iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab Product Code: [-] INN or Proposed INN: ECULIZUMAB Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: HAEMOPHILUS INFLUENZAE Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile Product Name: - Product Code: [-] INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135) Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml Product Name: - Product Code: [-] INN or Proposed INN: VACCINO PNEUMOCOCCICO | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;United Kingdom;France;Hungary;Canada;Brazil;Germany;Netherlands;Japan | ||
| 7 | EUCTR2019-004665-40-NL (EUCTR) | 20/11/2020 | 09/11/2020 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: iptacopan Product Code: LNP023 INN or Proposed INN: iptacopan Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris 300mg/30ml Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris 300mg/30ml Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Netherlands;Germany;Japan;Korea, Republic of | ||
| 8 | EUCTR2019-004665-40-HU (EUCTR) | 17/11/2020 | 23/09/2020 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB Trade Name: Ultomiris Product Name: Ravulizumab INN or Proposed INN: RAVULIZUMAB Other descriptive name: ravulizumab | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 91 | Phase 3 | United States;Taiwan;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of | ||
| 9 | EUCTR2019-004665-40-FR (EUCTR) | 03/11/2020 | 18/09/2020 | Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatment | A randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Product Name: LNP023 Product Code: LNP023 INN or Proposed INN: not yet established Other descriptive name: LNP023 HYDROCHLORIDE SALT Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 91 | Phase 3 | United States;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of | ||
| 10 | EUCTR2005-000043-28-ES (EUCTR) | 07/04/2006 | 21/10/2005 | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Germany;United Kingdom;Ireland;Spain;Italy;Sweden | ||
| 11 | EUCTR2005-000043-28-DE (EUCTR) | 06/07/2005 | 08/04/2005 | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria | Product Name: eculizumab Product Code: L04AA25 INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | United Kingdom;Germany;Spain;Ireland;Italy;Sweden | ||
| 12 | EUCTR2005-000043-28-IE (EUCTR) | 27/05/2005 | 06/04/2005 | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Spain;Ireland;Germany;Italy;United Kingdom;Sweden | ||
| 13 | EUCTR2005-000043-28-SE (EUCTR) | 24/05/2005 | 07/04/2005 | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Germany;United Kingdom;Spain;Ireland;Italy;Sweden | ||
| 14 | EUCTR2004-002795-42-ES (EUCTR) | 24/05/2005 | 22/02/2006 | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Spain;Ireland;Germany;Italy;United Kingdom;Sweden | ||
| 15 | EUCTR2004-002795-42-GB (EUCTR) | 20/04/2005 | 23/02/2005 | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Spain;Ireland;Germany;Italy;United Kingdom;Sweden | ||
| 16 | EUCTR2005-000043-28-GB (EUCTR) | 19/04/2005 | 16/03/2005 | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Ireland;Germany;Italy;United Kingdom;Sweden | ||
| 17 | EUCTR2004-002795-42-DE (EUCTR) | 24/03/2005 | 23/12/2004 | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 85 | United Kingdom;Germany;Spain;Ireland;Italy;Sweden | |||
| 18 | EUCTR2004-002795-42-SE (EUCTR) | 16/02/2005 | 09/12/2004 | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 85 | United Kingdom;Germany;Spain;Ireland;Italy;Sweden | |||
| 19 | EUCTR2004-002795-42-IE (EUCTR) | 03/02/2005 | 09/12/2004 | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Spain;Ireland;Germany;Italy;United Kingdom;Sweden | ||
| 20 | EUCTR2004-000646-20-GB (EUCTR) | 02/12/2004 | 14/02/2005 | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Ireland;Italy;United Kingdom;Sweden | ||
| 21 | EUCTR2004-000646-20-IE (EUCTR) | 26/10/2004 | 16/08/2004 | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Ireland;Italy;United Kingdom;Sweden | ||
| 22 | EUCTR2004-000646-20-SE (EUCTR) | 21/09/2004 | 19/07/2004 | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH | paroxysmal nocturnal hemoglobinuria MedDRA version: 7.0;Level: PT;Classification code 10034042 | Product Name: eculizumab INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 75 | Ireland;Italy;Sweden | |||
| 23 | EUCTR2009-010402-11-Outside-EU/EEA (EUCTR) | 30/04/2012 | Not Applicable | AN OPEN-LABEL MULTI-CENTER STUDY OF ECULIZUMAB IN CHILDREN AND ADOLESCENTS WITH A DIAGNOSIS OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA | PAROXYSMAL NOCTURNAL HEMOGLOBINURIA MedDRA version: 14.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | NA | Female: yes Male: yes | 6 | United States |
109. 非典型溶血性尿毒症症候群
臨床試験数 : 114 / 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11
| 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 | EUCTR2010-020326-18-FR (EUCTR) | 25/03/2013 | 21/09/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2010-020310-28-BE (EUCTR) | 09/11/2011 | 16/08/2011 | - | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) - Not Applicable | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | United States;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom | |||
| 3 | EUCTR2010-020310-28-ES (EUCTR) | 07/11/2011 | 08/09/2011 | - | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) - - | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Germany;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2010-020310-28-NL (EUCTR) | 07/07/2011 | 20/10/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2010-020326-18-NL (EUCTR) | 04/03/2011 | 19/10/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom | |||
| 6 | EUCTR2010-020310-28-GB (EUCTR) | 01/02/2011 | 21/10/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851 | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 7 | EUCTR2010-020326-18-BE (EUCTR) | 20/01/2011 | 27/09/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 13.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2010-020310-28-DE (EUCTR) | 17/01/2011 | 20/10/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 9 | EUCTR2010-020310-28-AT (EUCTR) | 16/12/2010 | 08/11/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 10 | EUCTR2010-020326-18-DE (EUCTR) | 26/11/2010 | 06/09/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 14.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851 | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Spain;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 11 | EUCTR2010-020326-18-GB (EUCTR) | 19/10/2010 | 26/08/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 14.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 12 | EUCTR2008-006955-28-DE (EUCTR) | 19/08/2009 | 19/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age weighing = 40 kg) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 13 | EUCTR2008-006953-41-DE (EUCTR) | 19/08/2009 | 19/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age weighing = 40 kg) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 7 | Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 14 | EUCTR2008-006952-23-DE (EUCTR) | 19/08/2009 | 19/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 15 | EUCTR2008-006954-17-NL (EUCTR) | 12/08/2009 | 26/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 16 | EUCTR2008-006955-28-NL (EUCTR) | 12/08/2009 | 26/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 17 | EUCTR2008-006952-23-NL (EUCTR) | 05/08/2009 | 26/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | France;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 18 | EUCTR2008-006953-41-NL (EUCTR) | 05/08/2009 | 26/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 7 | Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 19 | EUCTR2008-006954-17-DE (EUCTR) | 18/06/2009 | 19/02/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 20 | EUCTR2008-006952-23-AT (EUCTR) | 10/06/2009 | 18/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 21 | EUCTR2008-006954-17-AT (EUCTR) | 10/06/2009 | 18/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 22 | EUCTR2008-006955-28-AT (EUCTR) | 10/06/2009 | 18/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 23 | EUCTR2008-006953-41-AT (EUCTR) | 10/06/2009 | 18/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 7 | Phase 2 | Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 24 | EUCTR2008-006952-23-GB (EUCTR) | 28/05/2009 | 15/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 25 | EUCTR2008-006954-17-GB (EUCTR) | 28/05/2009 | 15/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 14.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 26 | EUCTR2008-006955-28-GB (EUCTR) | 28/05/2009 | 14/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 27 | EUCTR2008-006953-41-GB (EUCTR) | 28/05/2009 | 14/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 7 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 28 | EUCTR2008-006953-41-SE (EUCTR) | 15/04/2009 | 04/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 7 | Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 29 | EUCTR2008-006955-28-SE (EUCTR) | 15/04/2009 | 04/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 30 | EUCTR2008-006954-17-SE (EUCTR) | 15/04/2009 | 04/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 31 | EUCTR2008-006952-23-SE (EUCTR) | 15/04/2009 | 04/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | France;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 32 | EUCTR2008-006952-23-FR (EUCTR) | 09/04/2009 | 19/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-resistant Atypical Hemolytic-UremicSyndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 2 | United Kingdom;Sweden;Italy;France;Spain;Austria;Netherlands;Germany | ||
| 33 | EUCTR2008-006954-17-FR (EUCTR) | 09/04/2009 | 19/03/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden | |||
| 34 | EUCTR2010-020310-28-FR (EUCTR) | 05/11/2010 | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) | Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome | Trade Name: SOLIRIS INN or Proposed INN: eculizumab Other descriptive name: Anti-C5 antibody | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom |