R788, fostamatinib disodium hexahydrate (in USPI/FPI) ( DrugBank: Fostamatinib )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 61 | 自己免疫性溶血性貧血 | 21 |
61. 自己免疫性溶血性貧血
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| 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 | EUCTR2019-001882-34-NL (EUCTR) | 06/04/2021 | 05/01/2021 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Norway;Germany;Netherlands | ||
| 2 | EUCTR2018-004774-97-RO (EUCTR) | 25/08/2020 | 21/03/2022 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 3 | EUCTR2019-001882-34-DE (EUCTR) | 23/07/2020 | 13/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 4 | EUCTR2019-001882-34-DK (EUCTR) | 03/06/2020 | 20/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 5 | EUCTR2019-001882-34-IT (EUCTR) | 19/05/2020 | 30/07/2021 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia - C-935788-058 | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: [R935788] INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | RIGEL PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Belarus;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 6 | EUCTR2019-001882-34-FR (EUCTR) | 05/05/2020 | 06/02/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 7 | EUCTR2018-004774-97-NL (EUCTR) | 09/04/2020 | 09/10/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Germany;Netherlands | ||
| 8 | EUCTR2019-001882-34-HU (EUCTR) | 25/02/2020 | 27/02/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 9 | EUCTR2019-001882-34-AT (EUCTR) | 24/02/2020 | 15/01/2020 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Germany;Netherlands;Norway | ||
| 10 | EUCTR2019-001882-34-CZ (EUCTR) | 30/01/2020 | 20/12/2019 | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Georgia;Bulgaria;Norway;Germany;Netherlands | ||
| 11 | EUCTR2019-001882-34-ES (EUCTR) | 28/01/2020 | 02/12/2019 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 12 | EUCTR2019-001882-34-GB (EUCTR) | 20/01/2020 | 10/12/2019 | This is a Phase 3 multi-center, open-label extension study to evaluate the long-term safety and efficacy of fostamatinib (R788) in subjects with wAIHA who have completed 24 weeks of participation in study C-935788-057. | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 13 | EUCTR2018-004774-97-DK (EUCTR) | 15/11/2019 | 20/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Norway;Netherlands;Germany;Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria | ||
| 14 | EUCTR2018-004774-97-GB (EUCTR) | 23/10/2019 | 04/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 15 | EUCTR2018-004774-97-DE (EUCTR) | 10/10/2019 | 26/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 16 | EUCTR2018-004774-97-BE (EUCTR) | 30/09/2019 | 09/08/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 17 | EUCTR2018-004774-97-AT (EUCTR) | 27/09/2019 | 27/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Denmark;Australia;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 18 | EUCTR2018-004774-97-ES (EUCTR) | 09/09/2019 | 11/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Belarus;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 19 | EUCTR2018-004774-97-BG (EUCTR) | 05/09/2019 | 04/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Netherlands;Norway;Germany | ||
| 20 | EUCTR2018-004774-97-CZ (EUCTR) | 05/09/2019 | 13/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany | ||
| 21 | EUCTR2018-004774-97-HU (EUCTR) | 06/08/2019 | 17/06/2019 | This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R788) vs. placebo in increasing hemoglobin in subjects with warm antibody autoimmune hemolytic anemia (wAIHA) who have failed at least one prior treatment regimen. | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm antibody autoimmune hemolytic anemia (wAIHA) MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) Product Name: Fostamatinib Disodium Product Code: R935788 INN or Proposed INN: Fostamatinib Other descriptive name: R788, fostamatinib disodium hexahydrate (in USPI/FPI) | Rigel Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany |