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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002057-11-PL (EUCTR) | 15/02/2018 | 11/08/2017 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Taiwan;Poland;Lithuania | ||
| 2 | EUCTR2017-002057-11-LT (EUCTR) | 15/09/2017 | 10/08/2017 | A 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 Corporation | NULL | Authorised-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): no | United States;Taiwan;Poland;Lithuania | ||
| 3 | NCT03205995 (ClinicalTrials.gov) | February 23, 2017 | 17/4/2017 | Safety and Efficacy Study of OMS721 in Patients 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 | Thrombotic Microangiopathies;Atypical Hemolytic Uremic Syndrome | Biological: OMS721 | Omeros Corporation | NULL | Unknown status | 12 Years | N/A | All | 80 | Phase 3 | United States |
| 4 | EUCTR2014-001032-11-PL (EUCTR) | 22/10/2014 | 21/08/2014 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Taiwan;Hong Kong;Thailand;Malaysia;Belgium;Poland;Singapore;Lithuania;Bulgaria;New Zealand;Italy | ||
| 5 | EUCTR2014-001032-11-BE (EUCTR) | 10/10/2014 | 25/06/2014 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Belarus;Hong Kong;Taiwan;Thailand;Turkey;Lithuania;United Kingdom;Italy;Switzerland;Belgium;Malaysia;Poland;Bulgaria;Germany;New Zealand | ||
| 6 | EUCTR2014-001032-11-LT (EUCTR) | 30/09/2014 | 02/06/2014 | A 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 Corporation | NULL | Not Recruiting | Female: yes Male: yes | 89 | Phase 2 | United States;Taiwan;Hong Kong;Thailand;Poland;Malaysia;Belgium;Singapore;Lithuania;Bulgaria;New Zealand;Italy |