Oms721 (DrugBank: -)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 64 | 血栓性血小板減少性紫斑病 | 3 |
| 66 | IgA腎症 | 14 |
| 109 | 非典型溶血性尿毒症症候群 | 6 |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 |
| 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 | EUCTR2018-000075-33-DE (EUCTR) | 19/12/2019 | 01/07/2019 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 2 | EUCTR2018-000075-33-GB (EUCTR) | 06/11/2019 | 27/06/2019 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 3 | EUCTR2018-000075-33-AT (EUCTR) | 15/11/2018 | 25/06/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | |||
| 4 | EUCTR2018-000075-33-BE (EUCTR) | 03/10/2018 | 31/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Lithuania;Austria;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Sweden;Korea, Republic of | |||
| 5 | EUCTR2018-000075-33-PL (EUCTR) | 17/09/2018 | 10/07/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 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 |
| 6 | EUCTR2018-000075-33-CZ (EUCTR) | 06/09/2018 | 06/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 7 | EUCTR2018-000075-33-BG (EUCTR) | 05/09/2018 | 19/07/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 8 | EUCTR2018-000075-33-SE (EUCTR) | 03/09/2018 | 03/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 9 | EUCTR2018-000075-33-ES (EUCTR) | 01/08/2018 | 21/05/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Slovakia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Sweden | ||
| 10 | EUCTR2018-000075-33-SK (EUCTR) | 21/06/2018 | 20/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN) MedDRA version: 20.1;Level: PT;Classification code 10029151;Term: Nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Philippines;Taiwan;Slovakia;Spain;Thailand;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Malaysia;Singapore;Australia;Bulgaria;Germany;Sweden;Korea, Republic of | ||
| 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 |
| 11 | EUCTR2018-000075-33-LT (EUCTR) | 15/06/2018 | 23/04/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 INN or Proposed INN: OMS721 Other descriptive name: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Taiwan;Slovakia;Thailand;Spain;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Australia;Bulgaria;Germany;Korea, Republic of;Sweden | ||
| 12 | EUCTR2018-000075-33-HU (EUCTR) | 07/06/2018 | 29/03/2018 | OMS721 in patients with IgA Nephropathy (ARTEMIS-IGAN) | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (ARTEMIS – IGAN) - ARTEMIS-IGAN | IgA nephropathy (IgAN);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: OMS721 | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 434 | Phase 3 | United States;Hungary;Canada;Australia | ||
| 13 | NCT03608033 (ClinicalTrials.gov) | February 16, 2018 | 21/6/2018 | Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy | A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN) | IgA Nephropathy | Biological: OMS721;Other: Vehicle (D5W or saline) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 450 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Hungary;Lithuania;Poland;Slovakia;Spain |
| 14 | NCT02682407 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721 | A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Dense Deposit Disease | IgAN;Lupus Nephritis;MN;C3 Glomerulopathy | Biological: OMS721 (narsoplimab) | Omeros Corporation | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | United States;Hong Kong |
| 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] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | 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] | Omeros Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | 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 | ||
| 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 |
| 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 |