RVA576 (COVERSIN) ( DrugBank: COVERSIN )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
62発作性夜間ヘモグロビン尿症4
109非典型溶血性尿毒症症候群3

62. 発作性夜間ヘモグロビン尿症


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004129-18-LT
(EUCTR)
15/03/201929/01/2019An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: COVERSIN
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India
2EUCTR2016-004129-18-GB
(EUCTR)
17/03/201721/12/2016An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: rVA576
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
3NCT03829449
(ClinicalTrials.gov)
March 13, 201720/12/2018rVA576 (Coversin) Long Term Safety and Efficacy Surveillance StudyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance StudyParoxysmal Nocturnal HemoglobinuriaDrug: rVA576 (Coversin)AKARI TherapeuticsNULLTerminated18 YearsN/AAll15Phase 3Poland
4EUCTR2016-004129-18-PL
(EUCTR)
07/03/201718/01/2017An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;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: rVA576 (Coversin)
Product Code: rVA576
INN or Proposed INN: rVA576 (COVERSIN)
Other descriptive name: rVA576 (COVERSIN)
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom

109. 非典型溶血性尿毒症症候群


臨床試験数 : 115 薬物数 : 37 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-004129-18-LT
(EUCTR)
15/03/201929/01/2019An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: COVERSIN
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India
2EUCTR2016-004129-18-GB
(EUCTR)
17/03/201721/12/2016An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: rVA576
INN or Proposed INN: rVA576
Other descriptive name: rVA576
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom
3EUCTR2016-004129-18-PL
(EUCTR)
07/03/201718/01/2017An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial studyCONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
MedDRA version: 21.1;Level: PT;Classification code 10018932;Term: Haemolytic uraemic syndrome;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 21.1;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: rVA576 (Coversin)
Product Code: rVA576
INN or Proposed INN: rVA576 (COVERSIN)
Other descriptive name: rVA576 (COVERSIN)
Akari Therapeutics PlcNULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom