Alxn1210 (DrugBank: -)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 7 |
| 11 | 重症筋無力症 | 5 |
| 13 | 多発性硬化症／視神経脊髄炎 | 4 |
| 62 | 発作性夜間ヘモグロビン尿症 | 32 |
| 109 | 非典型溶血性尿毒症症候群 | 17 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004619-30-DK (EUCTR) | 12/08/2020 | 03/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2019-004619-30-DE (EUCTR) | 07/08/2020 | 11/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2019-004619-30-SE (EUCTR) | 22/06/2020 | 04/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2019-004619-30-GB (EUCTR) | 26/05/2020 | 07/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2019-004619-30-FR (EUCTR) | 20/05/2020 | 20/08/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;Italy;Switzerland;United Kingdom;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;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 |
| 6 | EUCTR2019-004619-30-ES (EUCTR) | 14/05/2020 | 06/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;Japan;Sweden;Korea, Republic of | ||
| 7 | EUCTR2019-004619-30-NL (EUCTR) | 23/04/2020 | 09/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;Japan;Sweden;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003243-39-PT (EUCTR) | 15/06/2020 | 06/02/2020 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2 | EUCTR2018-003243-39-GB (EUCTR) | 11/02/2020 | 08/10/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2018-003243-39-AT (EUCTR) | 09/10/2019 | 26/04/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | Portugal;United States;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2018-003243-39-DK (EUCTR) | 20/09/2019 | 22/05/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 5 | EUCTR2018-003243-39-DE (EUCTR) | 30/07/2019 | 25/03/2019 | Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis | 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: Ultomiris Product Name: Ravulizumab 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United States;Portugal;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003352-37-NL (EUCTR) | 11/06/2020 | 24/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 2 | EUCTR2019-003352-37-DE (EUCTR) | 11/05/2020 | 06/01/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 3 | EUCTR2019-003352-37-AT (EUCTR) | 27/03/2020 | 13/02/2020 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 4 | EUCTR2019-003352-37-DK (EUCTR) | 15/01/2020 | 19/12/2019 | Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD. | A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD | Neuromyelitis Optica Spectrum Disorder MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003440-74-GB (EUCTR) | 14/05/2020 | 17/03/2020 | Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab | Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab - ALXN1210-PNH-401 | 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] | Trade Name: ULTOMIRIS Product Name: ULTOMIRIS Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | United Kingdom | ||
| 2 | EUCTR2017-002370-39-AT (EUCTR) | 01/04/2019 | 24/01/2019 | This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab | A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria 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: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Finland;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 3 | EUCTR2017-002370-39-SE (EUCTR) | 27/03/2019 | 30/11/2018 | This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab | A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria 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: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Trade Name: ULTOMIRIS Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Finland;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Brazil;Australia;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 4 | EUCTR2017-002370-39-BE (EUCTR) | 13/03/2019 | 23/11/2018 | This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab | A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label,Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab | Paroxysmal Nocturnal Hemoglobinuria 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: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Finland;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Brazil;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 5 | EUCTR2017-002820-26-NL (EUCTR) | 21/03/2018 | 10/01/2018 | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 3 | France;United States;Netherlands;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03406507 (ClinicalTrials.gov) | February 22, 2018 | 5/1/2018 | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Biological: ALXN1210 | Alexion Pharmaceuticals | NULL | Recruiting | N/A | 18 Years | All | 13 | Phase 3 | United States;France;Netherlands;Norway;Russian Federation;United Kingdom |
| 7 | EUCTR2017-002820-26-GB (EUCTR) | 24/11/2017 | 26/10/2017 | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | 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] - Blood and lymphatic diseases [C15] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: ALXN1210 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 13 | Phase 3 | United States;France;Russian Federation;Norway;Netherlands;United Kingdom | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | NCT03056040 (ClinicalTrials.gov) | June 5, 2017 | 14/2/2017 | ALXN1210 Versus Eculizumab in Adult Participants 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) | Biological: Ravulizumab;Biological: Eculizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 195 | Phase 3 | United States;Australia;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | 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 | ||
| 12 | EUCTR2016-002026-36-GB (EUCTR) | 30/05/2017 | 14/02/2017 | 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] | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Spain;Netherlands;Germany;United Kingdom | |||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 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 | 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 | ||
| 17 | EUCTR2016-002025-11-EE (EUCTR) | 20/02/2017 | 23/01/2017 | 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: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | 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 | |||
| 18 | EUCTR2016-002025-11-CZ (EUCTR) | 02/02/2017 | 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] | 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 | |||
| 19 | 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 | ||
| 20 | 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 | ||
| 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 | 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 | ||
| 22 | 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 | ||
| 23 | NCT02946463 (ClinicalTrials.gov) | December 20, 2016 | 25/10/2016 | ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) | 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) | Biological: Ravulizumab;Biological: Eculizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 246 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;France;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Russian Federation;Singapore;Spain;Sweden;Taiwan;Thailand;Turkey;United Kingdom;Colombia |
| 24 | 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 | ||
| 25 | 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 | ||
| 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 | NCT02605993 (ClinicalTrials.gov) | January 4, 2016 | 11/11/2015 | Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria;PNH | Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 26 | Phase 2 | Canada;France;Germany;Korea, Republic of;Spain;Taiwan;United Kingdom;Sweden |
| 27 | EUCTR2015-002674-20-DE (EUCTR) | 04/12/2015 | 11/08/2015 | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | 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: ALXN1210 Product Code: ALXN1210 INN or Proposed INN: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Sweden;Korea, Republic of;France;United States | ||
| 28 | EUCTR2015-002674-20-SE (EUCTR) | 30/11/2015 | 02/10/2015 | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 18.0;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: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | France;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Sweden | ||
| 29 | EUCTR2015-002674-20-ES (EUCTR) | 27/11/2015 | 05/10/2015 | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 18.0;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: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 2 | France;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Sweden | ||
| 30 | NCT02598583 (ClinicalTrials.gov) | November 2015 | 2/11/2015 | Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) | An Open-Label, Intrapatient, Dose-Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria | PNH | Biological: ALXN1210 | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 13 | Phase 1;Phase 2 | Australia;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 |
| 31 | EUCTR2015-002674-20-GB (EUCTR) | 28/10/2015 | 01/10/2015 | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria | 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] | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Phase 2 | France;United States;Taiwan;Canada;Finland;Spain;Russian Federation;Germany;United Kingdom;Korea, Republic of;Sweden | |||
| 32 | EUCTR2017-002820-26-FR (EUCTR) | 12/01/2018 | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210 | Alexion Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 12 | Phase 3 | United States;France;Netherlands |
| 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 | EUCTR2016-002499-29-FR (EUCTR) | 07/06/2019 | 15/03/2018 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 3 | United States;France;Belgium;Spain;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 2 | NCT03131219 (ClinicalTrials.gov) | August 31, 2017 | 24/4/2017 | Study of Ravulizumab in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) | Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | N/A | 17 Years | All | 31 | Phase 3 | United States;Belgium;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom |
| 3 | EUCTR2016-002499-29-BE (EUCTR) | 18/08/2017 | 11/05/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden | ||
| 4 | EUCTR2016-002499-29-IT (EUCTR) | 16/08/2017 | 30/01/2018 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | 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 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | France;United States;Belgium;Spain;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2016-002027-29-BE (EUCTR) | 22/06/2017 | 28/02/2017 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | France;United States;Czech Republic;Spain;Belgium;Austria;Australia;Germany;Japan;United Kingdom;Sweden;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 |
| 6 | EUCTR2016-002499-29-SE (EUCTR) | 21/06/2017 | 21/03/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden | ||
| 7 | EUCTR2016-002499-29-ES (EUCTR) | 31/05/2017 | 31/03/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 3 | United States;Spain | ||
| 8 | EUCTR2016-002499-29-DE (EUCTR) | 24/05/2017 | 15/02/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden | ||
| 9 | EUCTR2016-002499-29-GB (EUCTR) | 18/05/2017 | 09/02/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Product Code: ALXN1210 INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5 Other descriptive name: Ravulizumab | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;Korea, Republic of;Sweden | ||
| 10 | EUCTR2016-002499-29-AT (EUCTR) | 28/04/2017 | 08/03/2017 | Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: Ravulizumab Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 23 | Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Japan;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 |
| 11 | EUCTR2016-002027-29-SE (EUCTR) | 19/04/2017 | 16/02/2017 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 20.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000012947;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 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | United States;France;Czech Republic;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Japan;Korea, Republic of;Sweden | ||
| 12 | NCT02949128 (ClinicalTrials.gov) | March 18, 2017 | 25/10/2016 | Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) | Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 12 Years | N/A | All | 58 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Russian Federation;Spain;Taiwan;United Kingdom |
| 13 | EUCTR2016-002027-29-DE (EUCTR) | 06/02/2017 | 21/10/2016 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | 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 | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | United States;France;Czech Republic;Belgium;Spain;Austria;Australia;Germany;United Kingdom;Japan;Sweden;Korea, Republic of | ||
| 14 | EUCTR2016-002027-29-ES (EUCTR) | 18/01/2017 | 17/11/2016 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Atypical Hemolytic Uremic Syndrome (aHUS) MedDRA version: 19.0;Level: LLT;Classification code 10019515;Term: Hemolytic uremic syndrome;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Code: ALXN1210 INN or Proposed INN: ALXN1210 Other descriptive name: ALXN1210 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;Spain;Austria | ||
| 15 | EUCTR2016-002027-29-AT (EUCTR) | 15/12/2016 | 11/11/2016 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | 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 | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | United States;France;Czech Republic;Belgium;Spain;Australia;Austria;Germany;United Kingdom;Japan;Sweden;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 | EUCTR2016-002027-29-GB (EUCTR) | 24/11/2016 | 07/10/2016 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Alexion Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 3 | France;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of | |||
| 17 | EUCTR2016-002027-29-CZ (EUCTR) | 22/03/2017 | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS) | 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] | Alexion Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 3 | France;United States;Czech Republic;Belgium;Spain;Austria;Australia;Germany;Japan;United Kingdom;Sweden;Korea, Republic of |