61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details


臨床試験数 : 137 薬物数 : 139 - (DrugBank : 55) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 152

  
24 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-NL
(EUCTR)
06/04/202105/01/2021This 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 3Belarus;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
2EUCTR2019-001882-34-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 3Belarus;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
3EUCTR2019-001882-34-DK
(EUCTR)
03/06/202020/01/2020This 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
81Phase 3Belarus;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
4EUCTR2019-001882-34-IT
(EUCTR)
19/05/202030/07/2021This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Belarus;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
5EUCTR2019-001882-34-FR
(EUCTR)
05/05/202006/02/2020This 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
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
6EUCTR2018-004774-97-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
7EUCTR2019-001882-34-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
8EUCTR2019-001882-34-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;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Bulgaria;Georgia;Germany;Netherlands;Norway
9EUCTR2019-001882-34-CZ
(EUCTR)
30/01/202020/12/2019A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United 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
10EUCTR2019-001882-34-ES
(EUCTR)
28/01/202002/12/2019This 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 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): noSerbia;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
11EUCTR2019-001882-34-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
12EUCTR2018-004774-97-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 (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.NULLNot RecruitingFemale: yes
Male: yes
90Phase 3Norway;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
13NCT04138927
(ClinicalTrials.gov)
October 30, 201923/10/2019A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaA Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib disodiumRigel PharmaceuticalsNULLEnrolling by invitation18 Years100 YearsAll90Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Italy;Netherlands;Norway;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
14EUCTR2018-004774-97-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
15EUCTR2018-004774-97-IT
(EUCTR)
16/10/201922/01/2021This 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 - C-935788-057 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]
Trade Name: na
Product Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
Product Name: Fostamatinib Disodium
Product Code: [R935788]
INN or Proposed INN: Fostamatinib
RIGEL PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3Belarus;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
16EUCTR2018-004774-97-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 (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.NULLNot RecruitingFemale: 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;Georgia;Bulgaria;Norway;Netherlands;Germany
17EUCTR2018-004774-97-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 (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.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;Georgia;Bulgaria;Norway;Netherlands;Germany
18EUCTR2018-004774-97-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 (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.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;Georgia;Bulgaria;Norway;Netherlands;Germany
19EUCTR2018-004774-97-ES
(EUCTR)
09/09/201911/06/2019This 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 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): noSerbia;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
20EUCTR2018-004774-97-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 (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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Serbia;Belarus;Czechia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Romania;Australia;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany
21EUCTR2018-004774-97-CZ
(EUCTR)
05/09/201913/06/2019This 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 (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.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;Hungary;Czech Republic;Canada;Belgium;Romania;Australia;Denmark;Georgia;Bulgaria;Norway;Netherlands;Germany
22EUCTR2018-004774-97-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
23NCT03764618
(ClinicalTrials.gov)
April 24, 20193/12/2018A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHAA Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib disodium;Drug: PlaceboRigel PharmaceuticalsNULLActive, not recruiting18 Years100 YearsAll90Phase 3United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
24NCT02612558
(ClinicalTrials.gov)
July 201619/11/2015A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic AnemiaWarm Antibody Autoimmune Hemolytic AnemiaDrug: Fostamatinib 150 mg bidRigel PharmaceuticalsNULLCompleted18 YearsN/AAll26Phase 2United States;Canada