44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
| 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 | EUCTR2011-001219-30-DE (EUCTR) | 17/01/2012 | 20/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 2 | EUCTR2011-001219-30-GB (EUCTR) | 08/11/2011 | 12/07/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 3 | NCT01446211 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis) | Wegeners Granulomatosis | Drug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids | Nordic Pharma SAS | NULL | Terminated | 18 Years | 75 Years | Both | 4 | Phase 3 | Czech Republic |
| 4 | EUCTR2011-001219-30-ES (EUCTR) | 14/10/2011 | 04/07/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener?s Granulomatosis) - SPARROW study ? SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener?s granulomatosis) | Relapse of Wegener?s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden | |||
| 5 | EUCTR2011-001219-30-SK (EUCTR) | 28/09/2011 | 05/10/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 6 | EUCTR2011-001219-30-SE (EUCTR) | 31/08/2011 | 21/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 7 | EUCTR2011-001219-30-CZ (EUCTR) | 18/08/2011 | 20/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden |