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 | 15 |
109 | 非典型溶血性尿毒症症候群 | 29 |
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 |
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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 |
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 |
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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 |
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 |
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1 | NCT04558918 (ClinicalTrials.gov) | December 15, 2020 | 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 | Not yet recruiting | 18 Years | N/A | All | 91 | Phase 3 | NULL |
2 | 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: 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;Italy;United Kingdom;France;Hungary;Canada;Brazil;Netherlands;Germany;Japan;Korea, Republic of | ||
3 | 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 | Authorised-recruitment may be ongoing or finished | 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 | ||
4 | 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 | ||
5 | 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 | ||
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 |
6 | 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 | ||
7 | 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 | ||
8 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 85 | United Kingdom;Germany;Ireland;Spain;Italy;Sweden | |||
9 | 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 | ||
10 | 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 | |||
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 |
11 | 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 | |||
12 | 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 | ||
13 | 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 | ||
14 | 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 | |||
15 | 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 |
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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United Kingdom;Canada;Netherlands;Belgium;Spain;Italy;United States;Austria;Australia | |||
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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | United Kingdom;Netherlands;Belgium;Spain;Italy;Austria | |||
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 | |||
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 |
6 | 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 | ||
7 | 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 | |||
8 | 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 | |||
9 | 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 | |||
10 | 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 | |||
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 |
11 | 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 | |||
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 | EUCTR2008-006955-28-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 | |||
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 | |||
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 |
16 | 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 | |||
17 | 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 | |||
18 | 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 | |||
19 | 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 | |||
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 | |||
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 |
21 | 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 | ||
22 | 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 | |||
23 | 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 | |||
24 | 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 | |||
25 | 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 | |||
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 |
26 | 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 | |||
27 | 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 | |||
28 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden | |||
29 | 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 |