Gusperimus ( DrugBank: Gusperimus )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
44多発血管炎性肉芽腫症7

44. 多発血管炎性肉芽腫症


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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2011-001219-30-DE
(EUCTR)
17/01/201220/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, 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 SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
2EUCTR2011-001219-30-GB
(EUCTR)
08/11/201112/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, 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 SASNULLNot 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): noFrance;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
3NCT01446211
(ClinicalTrials.gov)
November 201120/9/2011Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's GranulomatosisRandomised, 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 GranulomatosisDrug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoidsNordic Pharma SASNULLTerminated18 Years75 YearsBoth4Phase 3Czech Republic
4EUCTR2011-001219-30-ES
(EUCTR)
14/10/201104/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s GranulomatosisRandomised, 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 FranceNULLNot RecruitingFemale: yes
Male: yes
216United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden
5EUCTR2011-001219-30-SK
(EUCTR)
28/09/201105/10/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, 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 SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
6EUCTR2011-001219-30-SE
(EUCTR)
31/08/201121/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, 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 FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2011-001219-30-CZ
(EUCTR)
18/08/201120/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, 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 FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden