Soliris (DrugBank: -)
7 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 | 17 |
| 13 | 多発性硬化症／視神経脊髄炎 | 15 |
| 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 |
| 61 | 自己免疫性溶血性貧血 | 1 |
| 62 | 発作性夜間ヘモグロビン尿症 | 39 |
| 109 | 非典型溶血性尿毒症症候群 | 40 |
| 222 | 一次性ネフローゼ症候群 | 0 |
| 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 | EUCTR2016-001384-37-DE (EUCTR) | 07/10/2020 | 17/12/2018 | An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG) | An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis (gMG) | Refractory Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 17 | Phase 3 | United States;Canada;Germany;Japan | ||
| 2 | EUCTR2013-003589-15-CZ (EUCTR) | 22/04/2015 | 26/02/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom | ||
| 3 | EUCTR2013-003589-15-HU (EUCTR) | 31/03/2015 | 20/01/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 4 | EUCTR2013-002191-41-DE (EUCTR) | 23/12/2014 | 03/11/2014 | EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) | Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 5 | EUCTR2013-002191-41-SE (EUCTR) | 11/12/2014 | 13/11/2014 | EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) | Generalized Myasthenia Gravis MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;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 | EUCTR2013-002191-41-GB (EUCTR) | 27/10/2014 | 14/07/2014 | EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) | Generalized Myasthenia Gravis MedDRA version: 19.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Spain;Ireland;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 7 | EUCTR2013-002191-41-IT (EUCTR) | 05/10/2014 | 29/08/2014 | EXTENSION STUDY OF ECU-MG-301 TO EVALUATE ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-MG-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (gMG) | Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 8 | EUCTR2013-003589-15-NL (EUCTR) | 09/09/2014 | 24/02/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden | ||
| 9 | EUCTR2013-003589-15-FI (EUCTR) | 04/06/2014 | 09/05/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 10 | EUCTR2013-003589-15-BE (EUCTR) | 28/05/2014 | 10/02/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;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 | EUCTR2013-003589-15-FR (EUCTR) | 20/05/2014 | 17/06/2015 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | |||
| 12 | EUCTR2013-003589-15-DK (EUCTR) | 29/04/2014 | 04/03/2014 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 13 | EUCTR2013-003589-15-DE (EUCTR) | 07/04/2014 | 20/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden | ||
| 14 | EUCTR2013-003589-15-ES (EUCTR) | 24/02/2014 | 27/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden | ||
| 15 | EUCTR2013-003589-15-IT (EUCTR) | 11/02/2014 | 17/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;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 | EUCTR2013-003589-15-SE (EUCTR) | 03/02/2014 | 16/12/2013 | STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) | Generalized Myasthenia Gravis MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 3 | United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden | ||
| 17 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-001829-26-DE (EUCTR) | 19/10/2020 | 08/01/2020 | A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder | Neuromyelitis Optica Spectrum Disorder (NMOSD) MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Soliris Product Name: Soliris Product Code: Soliris INN or Proposed INN: ECULIZUMAB Other descriptive name: h5G1.1-mAb | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Phase 2;Phase 3 | United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of | ||
| 2 | EUCTR2013-001151-12-HR (EUCTR) | 08/12/2015 | 01/02/2016 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 3 | EUCTR2013-001150-10-HR (EUCTR) | 07/12/2015 | 01/02/2016 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000167619;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 4 | EUCTR2013-001150-10-CZ (EUCTR) | 22/04/2015 | 19/09/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 5 | EUCTR2013-001151-12-DK (EUCTR) | 25/03/2015 | 11/02/2015 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hong Kong;Taiwan;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Singapore;Croatia;Romania;Germany;Japan;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 | EUCTR2013-001150-10-DK (EUCTR) | 06/03/2015 | 11/02/2015 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Martinique;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Romania;Croatia;Germany;Japan;Sweden | ||
| 7 | EUCTR2013-001150-10-AT (EUCTR) | 16/09/2014 | 17/02/2014 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | neuromyelitis optica MedDRA version: 18.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 8 | EUCTR2013-001151-12-GB (EUCTR) | 18/02/2014 | 25/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Russian Federation;Colombia;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 9 | EUCTR2013-001150-10-GB (EUCTR) | 18/02/2014 | 25/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Switzerland;Italy;France;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;Sweden | ||
| 10 | EUCTR2013-001151-12-DE (EUCTR) | 12/12/2013 | 02/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Neuromyelitis Optica MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Germany;Japan;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 | EUCTR2013-001150-10-DE (EUCTR) | 12/12/2013 | 02/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - PREVENT | Neuromyelitis Optica MedDRA version: 19.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;United Arab Emirates;Saudi Arabia;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Denmark;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Germany;Japan;Sweden | ||
| 12 | EUCTR2013-001150-10-ES (EUCTR) | 17/10/2013 | 08/08/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Italy;Switzerland;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden | |||
| 13 | EUCTR2013-001151-12-ES (EUCTR) | 17/10/2013 | 08/08/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) | Relapsing Neuromyelitis Optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Hong Kong;Saudi Arabia;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Singapore;Germany;Japan;Sweden | ||
| 14 | EUCTR2013-001151-12-IT (EUCTR) | 17/09/2013 | 09/07/2013 | EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | Relapsing Neuromyelitis Optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Colombia;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;Sweden | ||
| 15 | EUCTR2013-001150-10-IT (EUCTR) | 17/09/2013 | 09/07/2013 | STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) - ECU-NMO-301 | Relapsing neuromyelitis optica MedDRA version: 16.0;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | United States;United Arab Emirates;Taiwan;Saudi Arabia;Hong Kong;Spain;Russian Federation;Chile;Switzerland;Italy;France;Peru;Australia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Singapore;Germany;Japan;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-016966-97-DE (EUCTR) | 08/06/2010 | 08/02/2010 | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial | Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial | Cold agglutinin disease MedDRA version: 12.1;Level: LLT;Classification code 10009868;Term: Cold type haemolytic anaemia | Trade Name: Soliris (R) | Universitätsklinikum Essen | NULL | Not Recruiting | Female: yes Male: yes | Germany |
| 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 | EUCTR2019-004931-21-GR (EUCTR) | 04/12/2020 | 16/10/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden | ||
| 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 | EUCTR2019-004931-21-HU (EUCTR) | 05/11/2020 | 08/09/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 3 | Hungary;United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden | ||
| 5 | EUCTR2019-004931-21-SE (EUCTR) | 26/10/2020 | 03/06/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;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 | EUCTR2017-001418-27-FI (EUCTR) | 01/04/2020 | 08/10/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden | ||
| 7 | EUCTR2017-001418-27-SE (EUCTR) | 20/02/2020 | 08/11/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - proposed biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden | ||
| 8 | EUCTR2017-001418-27-IE (EUCTR) | 15/01/2020 | 02/10/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden | ||
| 9 | EUCTR2017-001418-27-CZ (EUCTR) | 22/11/2019 | 05/08/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden | ||
| 10 | EUCTR2017-001418-27-SI (EUCTR) | 23/10/2019 | 10/09/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;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 | EUCTR2017-001418-27-NO (EUCTR) | 18/10/2019 | 22/08/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Czechia;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Norway;Germany;Netherlands;Sweden | ||
| 12 | EUCTR2019-001453-10-ES (EUCTR) | 16/09/2019 | 09/08/2019 | A Low-Interventional Study Documenting the Efficacy, Health-Related Quality of Life, and Safety of Standard-Of-Care Treatment with Eculizumab or Treatment with Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria | A MULTICENTER, LOW-INTERVENTIONAL STUDY DOCUMENTING THE EFFICACY, HEALTH-RELATED QUALITY OF LIFE, AND SAFETY OF STANDARD-OF-CARE TREATMENT WITH ECULIZUMAB OR TREATMENT WITH RAVULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA | Paroxysmal nocturnal hemoglobinuria (PNH) that is treated with either eculizumab or ravulizumab as per local label MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Soliris 300 Product Name: ECULIZUMAB INN or Proposed INN: ECULIZUMAB Trade Name: ULTOMIRIS Product Name: Ultomiris INN or Proposed INN: RAVULIZUMAB Other descriptive name: Ultomiris | Roche Farma S. A. U. que realiza el ensayo en España y que actua como representante F.Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United States;Taiwan;Greece;Spain;Turkey;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Romania;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 13 | NCT04058158 (ClinicalTrials.gov) | August 7, 2019 | 12/8/2019 | A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria | A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria | Drug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab) | Samsung Bioepis Co., Ltd. | NULL | Active, not recruiting | 18 Years | N/A | All | 50 | Phase 3 | India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine |
| 14 | NCT04060264 (ClinicalTrials.gov) | April 4, 2019 | 13/8/2019 | Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria | Randomized, Open-Label, International, Multi-center, Comparative Study of Efficacy and Safety of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Patients With Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria | Biological: BCD-148;Biological: Soliris | Biocad | NULL | Active, not recruiting | 18 Years | 65 Years | All | 28 | Phase 3 | Russian Federation |
| 15 | EUCTR2017-004268-36-IT (EUCTR) | 04/03/2019 | 26/09/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 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 | EUCTR2017-004268-36-GB (EUCTR) | 08/01/2019 | 21/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug Pegcetacoplan In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Pegcetacoplan (APL-2) Product Code: Pegcetacoplan (APL-2) INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 17 | EUCTR2017-004268-36-BE (EUCTR) | 25/10/2018 | 23/07/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 18 | EUCTR2017-004268-36-FR (EUCTR) | 05/10/2018 | 20/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 19 | EUCTR2017-004268-36-DE (EUCTR) | 01/10/2018 | 14/06/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Korea, Republic of | ||
| 20 | EUCTR2017-004268-36-ES (EUCTR) | 19/09/2018 | 07/08/2018 | A Research Study to Gather Scientific Information About the Efficacy, Safety, and Tolerability of the Investigational Drug APL-2 In Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH), a Disease Associated With Anemia, In A Randomly Assigned Comparison With the Current Standard of Care Treatment Approved for PNH At Multiple Research Centres. | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) - PEGASUS | PNH is an acquired, rare, clonal, non-malignant hematologic disease characterized by complement-mediated RBC hemolysis with or without hemoglobinuria, an increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction.PNH is caused by complement-mediated lysis of erythrocyte clones lacking functional CD55 and CD59 on their surface. These RBCs are particularly susceptible to the MAC and have been shown to lyse readily in the presence of complement activation. MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: APL-2 Product Code: APL-2 INN or Proposed INN: n/a Other descriptive name: n/a Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Apellis Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Canada;Spain;Australia;Russian Federation;Japan;Korea, Republic of | ||
| 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 | NCT03500549 (ClinicalTrials.gov) | June 14, 2018 | 10/4/2018 | Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria | Drug: APL-2;Drug: Soliris | Apellis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | N/A | All | 80 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom |
| 22 | NCT04463056 (ClinicalTrials.gov) | November 29, 2017 | 3/7/2020 | Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH | A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria;Marchiafava-Micheli Syndrome;Paroxysmal Hemoglobinuria | Biological: Elizaria®;Biological: Soliris® | AO GENERIUM | NULL | Completed | 18 Years | 75 Years | All | 32 | Phase 3 | Russian Federation |
| 23 | EUCTR2017-001418-27-ES (EUCTR) | 28/08/2017 | 31/07/2017 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | France;Spain;Russian Federation;Netherlands;Germany;Japan;Italy;United Kingdom;Korea, Republic of | ||
| 24 | EUCTR2016-002026-36-NL (EUCTR) | 27/07/2017 | 27/03/2017 | ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 197 | Phase 3 | United States;Spain;Germany;Netherlands;United Kingdom | ||
| 25 | EUCTR2016-002026-36-DE (EUCTR) | 14/06/2017 | 23/02/2017 | ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | France;United States;Canada;Spain;Australia;Netherlands;Germany;Japan;Italy;United Kingdom;Korea, Republic of | ||
| 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 | EUCTR2016-002026-36-ES (EUCTR) | 31/05/2017 | 22/03/2017 | ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently Treated With Eculizumab | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Spain;Germany | ||
| 27 | EUCTR2016-002025-11-FI (EUCTR) | 28/04/2017 | 01/11/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000012950;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden | ||
| 28 | EUCTR2016-002025-11-NL (EUCTR) | 27/03/2017 | 08/11/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Belgium;Poland;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 29 | EUCTR2016-002025-11-PL (EUCTR) | 16/03/2017 | 20/03/2017 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden | ||
| 30 | EUCTR2016-002025-11-BE (EUCTR) | 14/03/2017 | 17/10/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;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 |
| 31 | EUCTR2016-002025-11-PT (EUCTR) | 30/01/2017 | 21/10/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Poland;Spain;Austria;Denmark;Germany;United Kingdom;Korea, Republic of | ||
| 32 | EUCTR2016-002025-11-ES (EUCTR) | 16/01/2017 | 04/11/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 19.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Austria;Denmark;Germany;Korea, Republic of | ||
| 33 | EUCTR2016-002025-11-AT (EUCTR) | 11/01/2017 | 14/12/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | Portugal;United States;Estonia;Taiwan;Spain;Thailand;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden | ||
| 34 | EUCTR2016-002025-11-DK (EUCTR) | 23/12/2016 | 20/10/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.0;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Belgium;Poland;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 35 | EUCTR2016-002025-11-DE (EUCTR) | 20/12/2016 | 07/10/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | Portugal;United States;Taiwan;Estonia;Thailand;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;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 |
| 36 | EUCTR2016-002025-11-GB (EUCTR) | 02/12/2016 | 07/10/2016 | Study of ALXN1210 compared to eculizumab in PNH patients who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 Trade Name: Soliris INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 214 | Phase 3 | United States;Portugal;Estonia;Finland;Spain;Austria;United Kingdom;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Korea, Republic of;Sweden | ||
| 37 | EUCTR2019-004931-21-PL (EUCTR) | 18/09/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | NA | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;Sweden | |||
| 38 | 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 | ||||
| 39 | EUCTR2019-004931-21-DE (EUCTR) | 14/07/2020 | A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement Inhibitors | A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Crovalimab Product Code: RO7112689 INN or Proposed INN: CROVALIMAB Trade Name: Soliris Product Name: Eculizumab INN or Proposed INN: ECULIZUMAB | F. Hoffman-La Roche Ltd. | NULL | NA | Female: yes Male: yes | 200 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Germany;Japan;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-003135-35-DE (EUCTR) | 20/06/2016 | 08/02/2016 | EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, ANDTREATMENT | EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, ANDTREATMENT - EVIDENCE | atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 19.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: SOLIRIS Product Name: SOLIRIS INN or Proposed INN: ECULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 4 | United Arab Emirates;United States;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Norway | ||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | |||
| 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-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 | |||
| 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 | EUCTR2010-020326-18-IT (EUCTR) | 14/01/2011 | 17/12/2010 | An open-label, multi-center clinical trial of eculizumab in adult patients with atypical hemolytic-uremic syndrome - ND | An open-label, multi-center clinical trial of eculizumab in adult patients with atypical hemolytic-uremic syndrome - ND | Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 9.1;Level: LLT;Classification code 10019515 | Trade Name: SOLIRIS | ALEXION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 30 | France;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 10 | EUCTR2010-020326-18-ES (EUCTR) | 12/01/2011 | 18/10/2010 | 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 | pacientes adultos con síndrome hemolítico urémico atípico; Adult patients with Atypical Hemolytic Uremic Syndrome (aHUS): MedDRA version: 12.1;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome | Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión INN or Proposed INN: ECULIZUMAB Other descriptive name: ECULIZUMAB | ALEXION PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Germany;United Kingdom;Netherlands;Belgium;Spain;Italy | |||
| 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 | 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 | |||
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 | |||
| 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-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 | |||
| 17 | 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 | |||
| 18 | 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 | |||
| 19 | 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 | |||
| 20 | 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 | |||
| 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 | EUCTR2008-006954-17-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 | |||
| 22 | EUCTR2008-006952-23-ES (EUCTR) | 10/06/2009 | 07/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) RESISTENTE A LA PLASMOTERAPIA | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) RESISTENTE A LA PLASMOTERAPIA | Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS)Pacientes adultos con síndrome hemolítico urémico atípico (SHUa) resistente a la plasmoterapia MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión INN or Proposed INN: ECULIZUMAB Other descriptive name: ECULIZUMAB | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 8 | United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden | |||
| 23 | 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 | |||
| 24 | EUCTR2008-006954-17-ES (EUCTR) | 10/06/2009 | 08/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO, DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) QUE RESPONDE A PLASMOTERAPIA | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO, DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADULTOS CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUa) QUE RESPONDE A PLASMOTERAPIA | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS)Pacientes adultos con síndrome hemolítico urémico atípico (SHUa) que responde a plasmoterapia MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión INN or Proposed INN: ECULIZUMAB Other descriptive name: ECULIZUMAB | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | United Kingdom;Germany;Netherlands;France;Spain;Italy;Austria;Sweden | |||
| 25 | 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 | |||
| 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 | EUCTR2008-006955-28-ES (EUCTR) | 10/06/2009 | 08/04/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADOLESCENTES CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUA) QUE RESPONDE A PLASMOTERAPIA | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)ESTUDIO CLÍNICO ABIERTO, MULTICÉNTRICO, CONTROLADO DE ADMINISTRACIÓN DE ECULIZUMAB EN PACIENTES ADOLESCENTES CON SÍNDROME HEMOLÍTICO URÉMICO ATÍPICO (SHUA) QUE RESPONDE A PLASMOTERAPIA | Adolescent patients (from 12 and up to 18 years of age) with plasma therapy sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).Pacientes adolescentes (de 12 a 18 años) con síndrome hemolítico urémico atípico (SHUa) que responde a plasmoterapia MedDRA version: 9.1;Level: LLT;Classification code 10018932;Term: Haemolytic uraemic syndrome | Trade Name: SOLIRIS 300 mg concentrado para solución para perfusión INN or Proposed INN: ECULIZUMAB Other descriptive name: ECULIZUMAB | ALEXION PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 15 | United Kingdom;Germany;Netherlands;Spain;Italy;Austria;Sweden | |||
| 27 | 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 | |||
| 28 | 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 | ||
| 29 | EUCTR2008-006953-41-IT (EUCTR) | 04/06/2009 | 11/12/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYRESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYRESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND | Adolescent patients (from 12 and up to 18 years of age) with plasma therapyresistant Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 12.1;Level: LLT;Classification code 10018933;Term: Haemolytic-uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: Eculizumab | ALEXION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 7 | Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 30 | EUCTR2008-006954-17-IT (EUCTR) | 04/06/2009 | 11/12/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-SENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND | Adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10018933;Term: Haemolytic-uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: Eculizumab | ALEXION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Austria;Netherlands;Germany;United Kingdom;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 |
| 31 | EUCTR2008-006955-28-IT (EUCTR) | 04/06/2009 | 11/12/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYSENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADOLESCENT PATIENTS WITH PLASMA THERAPYSENSITIVE ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) - ND | Adolescent patients (from 12 and up to 18 years of age) with plasma therapysensitive Atypical Hemolytic-Uremic Syndrome (aHUS). MedDRA version: 12.1;Level: LLT;Classification code 10018933;Term: Haemolytic-uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: Eculizumab | ALEXION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 15 | Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 32 | EUCTR2008-006952-23-IT (EUCTR) | 04/06/2009 | 11/12/2009 | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND | AN OPEN-LABEL, MULTI-CENTER CONTROLLED CLINICAL TRIAL OF ECULIZUMAB IN ADULT PATIENTS WITH PLASMA THERAPY-RESISTANT ATYPICAL HEMOLYTIC-UREMIC SYNDROME (AHUS) - ND | Adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 12.1;Level: LLT;Classification code 10018933;Term: Haemolytic-uraemic syndrome | Trade Name: SOLIRIS INN or Proposed INN: Eculizumab | ALEXION PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 8 | France;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 33 | 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 | |||
| 34 | 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 | |||
| 35 | 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 | |||
| 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 |
| 36 | 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 | |||
| 37 | 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 | |||
| 38 | 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 | |||
| 39 | EUCTR2015-003135-35-IT (EUCTR) | 20/04/2018 | EVIDENCE - EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, AND TREATMENT | EVIDENCE - EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, AND TREATMENT - EVIDENCE | atypical Hemolytic-Uremic Syndrome (aHUS) MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: SOLIRIS - 300 MG CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 30 ML (10 MG/ML) INN or Proposed INN: Eculizumab Other descriptive name: / | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 4 | United Arab Emirates;United States;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Norway | |||
| 40 | 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 |