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13

61. 自己免疫性溶血性貧血 [臨床試験数:90,薬物数:72(DrugBank:23),標的遺伝子数:19,標的パスウェイ数:147
Searched query = "Autoimmune hemolytic anemia", "AIHA", "WAIHA", "Cold agglutinin disease", "CAD", "Paroxysmal cold hemoglobinuria", "MAIHA", "Evans syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
13 / 90 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001882-34-DE
(EUCTR)
23/07/202013/01/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
2EUCTR2018-004774-97-NL
(EUCTR)
09/04/202009/10/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Serbia;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
3EUCTR2019-001882-34-HU
(EUCTR)
25/02/202027/02/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
4EUCTR2019-001882-34-AT
(EUCTR)
24/02/202015/01/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
5EUCTR2019-001882-34-CZ
(EUCTR)
30/01/202020/12/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-001882-34-GB
(EUCTR)
20/01/202010/12/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
7EUCTR2018-004774-97-DK
(EUCTR)
15/11/201920/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Hungary;Canada;Belgium;Romania;Denmark;Australia;Bulgaria;Georgia;Norway;Netherlands;Germany;United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic
8EUCTR2018-004774-97-GB
(EUCTR)
23/10/201904/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
9EUCTR2018-004774-97-DE
(EUCTR)
10/10/201926/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Germany;Norway;Netherlands;United States;Serbia;Belarus;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia
10EUCTR2018-004774-97-BE
(EUCTR)
30/09/201909/08/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004774-97-AT
(EUCTR)
27/09/201927/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
12EUCTR2018-004774-97-BG
(EUCTR)
05/09/201904/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Belarus;Serbia;United States;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
13EUCTR2018-004774-97-HU
(EUCTR)
06/08/201917/06/2019This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Russian Federation;Serbia;United States;Belarus;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany;Ukraine