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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
19 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-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]
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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;Netherlands;Germany
7EUCTR2019-001882-34-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
8EUCTR2018-004774-97-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
9NCT04138927
(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 PharmaceuticalsNULLActive, not recruiting18 Years100 YearsAll80Phase 3United States;Australia;Austria;Belgium;Czechia;France;Georgia;Germany;Italy
10EUCTR2018-004774-97-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
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-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
12EUCTR2018-004774-97-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
13EUCTR2018-004774-97-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
14EUCTR2018-004774-97-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]
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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;Netherlands;Germany
15EUCTR2018-004774-97-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 (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]
Rigel Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: 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;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-004774-97-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
17EUCTR2018-004774-97-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
18NCT03764618
(ClinicalTrials.gov)
April 1, 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 PharmaceuticalsNULLRecruiting18 Years100 YearsAll90Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Norway;Russian Federation;Serbia;Spain;United Kingdom
19NCT02612558
(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 PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll37Phase 2United States;Canada