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 : 271 薬物数 : 163 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 106

  
22 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
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agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2019-004665-40-CZ
(EUCTR)
31/03/202103/11/2020Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Trade Name: Ultomiris
Product Name: Ravulizumab
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ravulizumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Czechia;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
2JPRN-jRCT2051200132
26/03/202109/02/2021Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody TreatmentStudy of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment - APPLY-PNH Paroxysmal nocturnal hemoglobinuria
PNH
Arm A : LNP023 monotherapy
Arm B : Anti-C5 antibody treatment(Eculizumab or Ravulizumab)
Suzuki KazuyukiNULLNot Recruiting>= 18age oldNot applicableBoth91Phase 3Netherlands;Japan
3EUCTR2019-004665-40-DE
(EUCTR)
29/01/202122/09/2020Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris 300mg/30ml
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Trade Name: Ultomiris 300mg/30ml
Product Name: Ravulizumab
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ravulizumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
4NCT04558918
(ClinicalTrials.gov)
January 25, 202127/8/2020Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody TreatmentA Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.Paroxysmal Nocturnal Hemoglobinuria (PNH)Drug: LNP023;Drug: Eculizumab;Drug: RavulizumabNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll91Phase 3United States;Brazil;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Taiwan;United Kingdom
5EUCTR2019-004665-40-IT
(EUCTR)
23/12/202015/06/2021Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody - Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia d Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Iptacopan
Product Code: [LNP023]
INN or Proposed INN: Iptacopan
Other descriptive name: LNP023 HYDROCHLORIDE SALT
Product Name: Iptacopan
Product Code: [LNP023]
INN or Proposed INN: Iptacopan
Other descriptive name: LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris
Product Name: Eculizumab
Product Code: [-]
INN or Proposed INN: ECULIZUMAB
Trade Name: ACT-HIB Polvere e solvente per soluzione iniettabile in siringa preriempita 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: HAEMOPHILUS INFLUENZAE
Trade Name: MENVEO – Polvere e soluzione per soluzione iniettabile
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO POLISACCARIDICO ANTI-MENINGOCOCCICO (A.C.Y E W-135)
Trade Name: PNEUMOVAX – Soluzione iniettabile in siringa preriempita da 0,5 ml
Product Name: -
Product Code: [-]
INN or Proposed INN: VACCINO PNEUMOCOCCICO
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Czechia;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;United Kingdom;France;Hungary;Canada;Brazil;Germany;Netherlands;Japan
6EUCTR2019-004665-40-NL
(EUCTR)
20/11/202009/11/2020Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: iptacopan
Product Code: LNP023
INN or Proposed INN: iptacopan
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris 300mg/30ml
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Trade Name: Ultomiris 300mg/30ml
Product Name: Ravulizumab
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ravulizumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Czechia;Taiwan;Spain;Italy;United Kingdom;France;Hungary;Canada;Brazil;Netherlands;Germany;Japan;Korea, Republic of
7EUCTR2019-004665-40-HU
(EUCTR)
17/11/202023/09/2020Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Trade Name: Ultomiris
Product Name: Ravulizumab
INN or Proposed INN: RAVULIZUMAB
Other descriptive name: ravulizumab
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
91Phase 3United States;Taiwan;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
8EUCTR2019-004665-40-FR
(EUCTR)
03/11/202018/09/2020Study of efficacy and safety of twice daily oral LNP023 in adult PNH patients with residual anemia despite anti-C5 antibody treatmentA randomized, multicenter, active-comparator controlled, open-label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult patients with PNH and residual anemia, despite treatment with an intravenous anti-C5 antibody Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Product Name: LNP023
Product Code: LNP023
INN or Proposed INN: not yet established
Other descriptive name:  LNP023 HYDROCHLORIDE SALT
Trade Name: Soliris
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
91Phase 3United States;Taiwan;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Brazil;Germany;Netherlands;Japan;Korea, Republic of
9EUCTR2005-000043-28-ES
(EUCTR)
07/04/200621/10/2005A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 ExtensionA Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;United Kingdom;Ireland;Spain;Italy;Sweden
10EUCTR2005-000043-28-DE
(EUCTR)
06/07/200508/04/2005A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 ExtensionA Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria
Product Name: eculizumab
Product Code: L04AA25
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
170Phase 3United Kingdom;Germany;Spain;Ireland;Italy;Sweden
11EUCTR2005-000043-28-IE
(EUCTR)
27/05/200506/04/2005A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 ExtensionA Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
170Phase 3Spain;Ireland;Germany;Italy;United Kingdom;Sweden
12EUCTR2004-002795-42-ES
(EUCTR)
24/05/200522/02/2006Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERDSafety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
85Phase 3Spain;Ireland;Germany;Italy;United Kingdom;Sweden
13EUCTR2005-000043-28-SE
(EUCTR)
24/05/200507/04/2005A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 ExtensionA Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05-001 Extension paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
MedDRA version: 9.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
170Phase 3Germany;United Kingdom;Spain;Ireland;Italy;Sweden
14EUCTR2004-002795-42-GB
(EUCTR)
20/04/200523/02/2005Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERDSafety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
85Phase 3Spain;Ireland;Germany;Italy;United Kingdom;Sweden
15EUCTR2005-000043-28-GB
(EUCTR)
19/04/200516/03/2005A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 ExtensionA Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SHEPHERD (C04-002) or X03-001 Studies. - E05 Extension paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Ireland;Germany;Italy;United Kingdom;Sweden
16EUCTR2004-002795-42-DE
(EUCTR)
24/03/200523/12/2004Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERDSafety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
85United Kingdom;Germany;Spain;Ireland;Italy;Sweden
17EUCTR2004-002795-42-SE
(EUCTR)
16/02/200509/12/2004Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERDSafety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
85United Kingdom;Germany;Spain;Ireland;Italy;Sweden
18EUCTR2004-002795-42-IE
(EUCTR)
03/02/200509/12/2004Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERDSafety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
85Phase 3Spain;Ireland;Germany;Italy;United Kingdom;Sweden
19EUCTR2004-000646-20-GB
(EUCTR)
02/12/200414/02/2005 A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot Recruiting Female: yes
Male: yes
75 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4):Ireland;Italy;United Kingdom;Sweden
20EUCTR2004-000646-20-IE
(EUCTR)
26/10/200416/08/2004A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPHA Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
75Phase 3Ireland;Italy;United Kingdom;Sweden
21EUCTR2004-000646-20-SE
(EUCTR)
21/09/200419/07/2004A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPHA Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients - TRIUMPH paroxysmal nocturnal hemoglobinuria
MedDRA version: 7.0;Level: PT;Classification code 10034042
Product Name: eculizumab
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
75Ireland;Italy;Sweden
22EUCTR2009-010402-11-Outside-EU/EEA
(EUCTR)
30/04/2012Not ApplicableAN OPEN-LABEL MULTI-CENTER STUDY OF ECULIZUMAB IN CHILDREN AND ADOLESCENTS WITH A DIAGNOSIS OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PAROXYSMAL NOCTURNAL HEMOGLOBINURIA
MedDRA version: 14.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Other descriptive name: Anti-C5 antibody
ALEXION PHARMACEUTICALS, INC.NULLNAFemale: yes
Male: yes
6United States