109. 非典型溶血性尿毒症症候群 Atypical hemolytic uremic syndrome Clinical trials / Disease details


臨床試験数 : 114 薬物数 : 36 - (DrugBank : 7) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 11

  
6 trials found
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1EUCTR2017-002057-11-PL
(EUCTR)
15/02/201811/08/2017A study to investigate the safety and efficacy of study drug OMS721 in adults and adolescents with Atypical Hemolytic Uremic Syndrome.A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents. 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: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Taiwan;Poland;Lithuania
2EUCTR2017-002057-11-LT
(EUCTR)
15/09/201710/08/2017A study to investigate the safety and efficacy of study drug OMS721 in adults and adolescents with Atypical Hemolytic Uremic Syndrome.A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents. 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: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721 Drug Product 185 mg/mL
INN or Proposed INN: not yet available
Other descriptive name: OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Poland;Lithuania
3NCT03205995
(ClinicalTrials.gov)
February 23, 201717/4/2017Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic SyndromeA Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and AdolescentsThrombotic Microangiopathies;Atypical Hemolytic Uremic SyndromeBiological: OMS721Omeros CorporationNULLUnknown status12 YearsN/AAll80Phase 3United States
4EUCTR2014-001032-11-PL
(EUCTR)
22/10/201421/08/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Malaysia;Belgium;Poland;Singapore;Lithuania;Bulgaria;New Zealand;Italy
5EUCTR2014-001032-11-BE
(EUCTR)
10/10/201425/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of study drug OMS721 in adults with thrombotic microangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS) - hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 18.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Belarus;Hong Kong;Taiwan;Thailand;Turkey;Lithuania;United Kingdom;Italy;Switzerland;Belgium;Malaysia;Poland;Bulgaria;Germany;New Zealand
6EUCTR2014-001032-11-LT
(EUCTR)
30/09/201402/06/2014A study to investigate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of study drug OMS721 in adults with thromboticmicroangiopathies.A Phase 2, uncontrolled, three-stage, dose-escalation cohort study toevaluate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies. Three forms of thrombotic microangiopathies (TMA):- atypical hemolytic uremic syndrome (aHUS)- hematopoietic stem cell transplant (HSCT)-associated TMA- thrombotic thrombocytopenic purpura (TTP)
MedDRA version: 20.0;Level: PT;Classification code 10043645;Term: Thrombotic microangiopathy;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 100 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Product Code: OMS721
INN or Proposed INN: not yet available
Other descriptive name: OMS721 185 mg/ml Injection solution, OMS00620646, OMS620646, MASP-2 Antibody
Omeros CorporationNULLNot RecruitingFemale: yes
Male: yes
89Phase 2United States;Taiwan;Hong Kong;Thailand;Poland;Malaysia;Belgium;Singapore;Lithuania;Bulgaria;New Zealand;Italy