62. 発作性夜間ヘモグロビン尿症 Paroxysmal nocturnal hemoglobinuria Clinical trials / Disease details


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108

  
7 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2020-002761-33-FR
(EUCTR)
06/12/202221/03/2022Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal HemoglobinuriaA RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Trade Name: Soliris ™ (eculizumab)
Product Name: Eculizumab
INN or Proposed INN: Eculizumab
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Netherlands;Germany;Japan;Korea, Republic of
2EUCTR2020-002761-33-DE
(EUCTR)
20/06/202203/03/2022Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal HemoglobinuriaA RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Trade Name: Soliris ™ (eculizumab)
Product Name: Eculizumab
INN or Proposed INN: Eculizumab
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Brazil;Poland;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of
3EUCTR2020-002761-33-GR
(EUCTR)
17/06/202212/04/2022Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal HemoglobinuriaA RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED, NON-INFERIORITY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB - ACCESS-2 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Trade Name: Soliris ™ (eculizumab)
Product Name: Eculizumab
INN or Proposed INN: Eculizumab
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
134Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Thailand;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Brazil;Poland;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of
4EUCTR2020-004486-40-GR
(EUCTR)
17/06/202208/04/2022Ravulizumab-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria who are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor TherapyA RANDOMIZED, OPEN-LABEL, RAVULIZUMAB-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE COMPLEMENT INHIBITOR TREATMENT-NAIVE OR HAVE NOT RECENTLY RECEIVED COMPLEMENT INHIBITOR THERAPY 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 3Portugal;United States;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Jordan;Poland;Brazil;Malaysia;Singapore;Romania;Peru;South Africa;Netherlands;China;Japan;Korea, Republic of
5EUCTR2020-002761-33-ES
(EUCTR)
09/05/202211/03/2022Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal HemoglobinuriaA RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Trade Name: Soliris ™ (eculizumab)
Product Name: Eculizumab
INN or Proposed INN: Eculizumab
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Netherlands;Germany;Japan;Korea, Republic of
6EUCTR2020-004486-40-ES
(EUCTR)
09/05/202211/03/2022Ravulizumab-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria who are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor TherapyA RANDOMIZED, OPEN-LABEL, RAVULIZUMAB-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE COMPLEMENT INHIBITOR TREATMENT-NAIVE OR HAVE NOT RECENTLY RECEIVED COMPLEMENT INHIBITOR THERAPY 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
124Phase 3Portugal;United States;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Canada;Jordan;Poland;Brazil;Malaysia;Singapore;Romania;Peru;South Africa;Netherlands;China;Japan;Korea, Republic of
7EUCTR2020-002761-33-PL
(EUCTR)
14/04/202222/03/2022Efficacy and Safety of the Combination of Pozelimab and Cemdisiran versus continued Eculizumab or Ravulizumab Treatment in Adult Patients with Paroxysmal Nocturnal HemoglobinuriaA RANDOMIZED, OPEN-LABEL ECULIZUMAB AND RAVULIZUMAB CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF POZELIMAB AND CEMDISIRAN COMBINATION THERAPY IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WHO ARE CURRENTLY TREATED WITH ECULIZUMAB OR RAVULIZUMAB 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: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: CEMDISIRAN
Other descriptive name: CEMDISIRAN
Trade Name: ULTOMIRIS ™ (ravulizumab-cwvz)
INN or Proposed INN: Ravulizumab
Other descriptive name: Ravulizumab
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Trade Name: Soliris ™ (eculizumab)
Product Name: Eculizumab
INN or Proposed INN: Eculizumab
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;France;Mexico;Poland;Brazil;Singapore;Romania;Germany;Netherlands;Japan;Korea, Republic of