Rva576 (DrugBank: -)
3 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 | 8 |
| 109 | 非典型溶血性尿毒症症候群 | 5 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 3 |
| 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 | EUCTR2016-004129-18-LT (EUCTR) | 15/03/2019 | 29/01/2019 | An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India | ||
| 2 | NCT03588026 (ClinicalTrials.gov) | June 7, 2018 | 1/6/2018 | Treating Paroxysmal Nocturnal Haemoglobinuria Patients With rVA576 | Investigational Product ; Coversin. Phase III Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in Patients With Paroxysmal Nocturnal Haemoglobinuria (PNH) | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: rVA576;Other: Standard of care (SOC) | AKARI Therapeutics | NULL | Completed | 18 Years | N/A | All | 9 | Phase 3 | Kazakhstan;Lithuania;Sri Lanka |
| 3 | EUCTR2017-003847-39-LT (EUCTR) | 12/03/2018 | 23/01/2018 | A study to assess the safety and efficacy of rVA576 in patients with Paroxysmal Nocturnal Haemoglobinuria (PNH) | CAPSTONE: Phase III Confirmatory Assessment Protocol: rVA576 Safety and Efficacy in Three-Part, Two-Arm, Randomised Open Label Evaluation in patients with Paroxysmal Nocturnal Haemoglobinuria (PNH) - CAPSTONE | Paroxysmal Nocturnal Haemoglobinuria (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 Code: rVA576 INN or Proposed INN: NA | Akari Therapeutics Plc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Ecuador;Turkey;Romania;Lithuania;Peru;Kazakhstan;Sri Lanka | ||
| 4 | EUCTR2016-004129-18-NL (EUCTR) | 14/02/2018 | 16/11/2017 | An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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: Coversin Product Code: rVA576 INN or Proposed INN: COVERSIN Other descriptive name: COVERSIN | Akari Therapeutics Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Argentina;Poland;Lithuania;Netherlands;United Kingdom | ||
| 5 | EUCTR2016-004129-18-GB (EUCTR) | 17/03/2017 | 21/12/2016 | An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom | ||
| 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 | NCT03829449 (ClinicalTrials.gov) | March 13, 2017 | 20/12/2018 | rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | Paroxysmal Nocturnal Hemoglobinuria;Atypical Hemolytic Uremic Syndrome | Drug: rVA576 (Coversin) | AKARI Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 3 | Poland |
| 7 | EUCTR2016-004129-18-PL (EUCTR) | 07/03/2017 | 18/01/2017 | An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom | ||
| 8 | EUCTR2015-003778-34-NL (EUCTR) | 13/01/2016 | 10/12/2015 | Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms | Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms - Coversin in PNH patients with resistance to Eculizumab | Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms. MedDRA version: 18.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Coversin Product Code: rVA576 INN or Proposed INN: Not applicable Other descriptive name: coversin | Volution Immuno Pharmaceuticals (UK) Ltd | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Netherlands |
| 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 | EUCTR2016-004129-18-LT (EUCTR) | 15/03/2019 | 29/01/2019 | An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom;India | ||
| 2 | EUCTR2016-004129-18-NL (EUCTR) | 14/02/2018 | 16/11/2017 | An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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: Coversin Product Code: rVA576 INN or Proposed INN: COVERSIN Other descriptive name: COVERSIN | Akari Therapeutics Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Argentina;Poland;Lithuania;Netherlands;United Kingdom | ||
| 3 | EUCTR2016-004129-18-GB (EUCTR) | 17/03/2017 | 21/12/2016 | An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom | ||
| 4 | NCT03829449 (ClinicalTrials.gov) | March 13, 2017 | 20/12/2018 | rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study | Paroxysmal Nocturnal Hemoglobinuria;Atypical Hemolytic Uremic Syndrome | Drug: rVA576 (Coversin) | AKARI Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 3 | Poland |
| 5 | EUCTR2016-004129-18-PL (EUCTR) | 07/03/2017 | 18/01/2017 | An extension study on Coversin for Patients with PNH and aHUS who received benefit from their initial study | CONSERVE: 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 Plc | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;Argentina;Poland;Lithuania;Kazakhstan;Netherlands;Germany;Sri Lanka;United Kingdom |
| 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 | NCT04035733 (ClinicalTrials.gov) | September 25, 2018 | 12/4/2019 | rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects | A Phase IIa Open-label Single Arm Study of Safety and Efficacy of rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects | Bullous Pemphigoid (BP) | Biological: rVA576 | AKARI Therapeutics | NULL | Completed | 18 Years | N/A | All | 9 | Phase 2 | Germany;Netherlands |
| 2 | EUCTR2017-002836-18-DE (EUCTR) | 23/07/2018 | 14/02/2018 | A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters) | A Phase IIa open label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects | Mild to Moderate Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: rVA576 INN or Proposed INN: rVA576 | Akari Therapeutics Plc. | NULL | Not Recruiting | Female: yes Male: yes | 9 | Phase 2 | Netherlands;Germany | ||
| 3 | EUCTR2017-002836-18-NL (EUCTR) | 07/05/2018 | 24/01/2018 | A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters) | A Phase IIa open label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects | Mild to Moderate Bullous Pemphigoid MedDRA version: 20.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: rVA576 INN or Proposed INN: rVA576 | Akari Therapeutics Plc. | NULL | Not Recruiting | Female: yes Male: yes | 9 | Phase 2 | Germany;Netherlands |