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

  
27 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2019-004931-21-RO
(EUCTR)
14/02/202219/05/2022A 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 InhibitorsA 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden
2EUCTR2020-000597-26-IE
(EUCTR)
23/09/202113/01/2021A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and efficacy of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden
3EUCTR2019-004931-21-LT
(EUCTR)
15/07/202119/05/2021A 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 InhibitorsA 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
4EUCTR2019-004931-21-EE
(EUCTR)
30/06/202124/04/2021A 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 InhibitorsA 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Germany;Japan;Sweden
5EUCTR2020-000597-26-EE
(EUCTR)
30/06/202124/04/2021A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden
6EUCTR2019-004931-21-PT
(EUCTR)
19/05/202128/10/2020A 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 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]
Trade Name: Soliris 300 mg concentrate for solution for infusion
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Japan;Sweden
7EUCTR2020-000597-26-PT
(EUCTR)
18/05/202123/12/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689
INN or Proposed INN: CROVALIMAB
Trade Name: SOLIRIS® (eculizumab) injection, for intravenous use
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
8EUCTR2020-000597-26-CZ
(EUCTR)
28/04/202122/12/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Philippines;Taiwan;Hong Kong;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Germany;Japan;Sweden
9EUCTR2019-004931-21-FR
(EUCTR)
26/01/202118/09/2020A 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 InhibitorsA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United 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
10EUCTR2019-004931-21-BE
(EUCTR)
22/01/202123/11/2020A 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 InhibitorsA 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Hong Kong;Taiwan;Estonia;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
11EUCTR2020-000597-26-BE
(EUCTR)
11/01/202115/10/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden
12EUCTR2020-000597-26-GR
(EUCTR)
04/12/202016/10/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689
INN or Proposed INN: CROVALIMAB
Trade Name: Eculizumab
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Hong Kong;Taiwan;Greece;Spain;Thailand;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
13EUCTR2019-004931-21-GR
(EUCTR)
04/12/202016/10/2020A 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 InhibitorsA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United 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
14EUCTR2019-004931-21-DE
(EUCTR)
01/12/202014/07/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement InhibitorsA PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITH COMPLEMENT 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Germany;Japan;Sweden
15EUCTR2020-000597-26-DE
(EUCTR)
01/12/202014/07/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Belgium;Poland;Germany;Japan;Sweden
16EUCTR2019-004931-21-PL
(EUCTR)
24/11/202018/09/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously Treated with Complement InhibitorsA PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Germany;Japan;Sweden
17EUCTR2020-000597-26-PL
(EUCTR)
23/11/202016/09/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Spain;Thailand;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Brazil;Poland;Belgium;Germany;Japan;Sweden
18EUCTR2019-004931-21-HU
(EUCTR)
05/11/202008/09/2020A 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 InhibitorsA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 3Hungary;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
19EUCTR2019-004931-21-SE
(EUCTR)
26/10/202003/06/2020A 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 InhibitorsA 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/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Portugal;Philippines;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan;Sweden
20JPRN-JapicCTI-173517
17/10/201717/02/2017An adaptive Phase I/II study of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal Nocturnal HemoglobinuriaIntervention name : RO7112689
INN of the intervention : Crovalimab
Dosage And administration of the intervention : Intravenous and Subcutaneous
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
CHUGAI PHARMACEUTICAL CO., LTD.NULLcomplete1875BOTH44Phase 1-2Japan, Asia except Japan, Europe
21EUCTR2016-002128-10-IT
(EUCTR)
19/09/201706/02/2018Studio volto a valutare la sicurezza, l’efficacia, la farmacocinetica e la farmacodinamica di RO7112689 in volontari sani e in pazienti con Emoglobinuria Parossistica NotturnaAn adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) - An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO 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: RO7112689/F01
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
49Phase 1;Phase 2France;Hungary;Brazil;Netherlands;Germany;New Zealand;Japan;Italy;Korea, Republic of
22EUCTR2016-002128-10-FR
(EUCTR)
17/08/201708/09/2017A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal HemoglobinuriaAn adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and 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: RO7112689/F01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
49Phase 1;Phase 2France;Hungary;Netherlands;Germany;Japan;Italy;Korea, Republic of
23EUCTR2016-002128-10-DE
(EUCTR)
14/03/201724/10/2016A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal HemoglobinuriaAn adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and 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: RO7112689/F01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Code: RO7112689/F03-01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Code: RO7112689/F03-10
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
49Phase 1;Phase 2France;Hungary;Netherlands;Germany;Italy;Japan;Korea, Republic of
24EUCTR2016-002128-10-HU
(EUCTR)
24/01/201714/11/2016A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal HemoglobinuriaAn adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and 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: RO7112689/F01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
49Phase 1;Phase 2France;Hungary;Brazil;Netherlands;Germany;New Zealand;Japan;Italy;Korea, Republic of
25EUCTR2016-002128-10-NL
(EUCTR)
14/09/201605/09/2016A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Patients With Paroxysmal Nocturnal HemoglobinuriaAn adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and 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: RO7112689/F01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: no
Male: yes
74Phase 1;Phase 2France;Hungary;Czech Republic;Brazil;Germany;Netherlands;Japan;Italy;United Kingdom
26EUCTR2019-004931-21-IE
(EUCTR)
13/01/2021A 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 InhibitorsA 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]
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F. Hoffman-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Portugal;Philippines;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden
27EUCTR2020-000597-26-SE
(EUCTR)
02/06/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS 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]
Product Name: Crovalimab
Product Code: RO7112689/F03-01
INN or Proposed INN: CROVALIMAB
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Product Name: Crovalimab
Product Code: RO7112689/F03-10
INN or Proposed INN: CROVALIMAB
F.Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
250Phase 3United States;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Germany;Japan;Sweden