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"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04256148
(ClinicalTrials.gov)
July 202127/1/2020ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic AnemiaBiological: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
2NCT04661033
(ClinicalTrials.gov)
January 1, 20211/12/2020Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic AnemiaA Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic AnemiaDrug: Isatuximab SAR650984SanofiNULLNot yet recruiting18 YearsN/AAll23Phase 1;Phase 2NULL
3EUCTR2020-003675-18-DE
(EUCTR)
16/12/202028/09/2020Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Hungary;Spain;Austria;Norway;Netherlands;Germany;United Kingdom;Italy
4NCT04657094
(ClinicalTrials.gov)
December 10, 20201/12/2020Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic LeukemiaA Phase 2 Trial of Acalabrutinib for the Treatment of Relapsed/Refractory Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Anemia;Chronic Lymphocytic Leukemia;Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Warm Antibody Autoimmune Hemolytic AnemiaDrug: AcalabrutinibCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 YearsN/AAll22Phase 2United States
5EUCTR2019-003924-19-HU
(EUCTR)
07/10/202017/08/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA Warm Autoimmune Hemolytic Anemia
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: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401
Immunovant Sciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United States;Hungary;Thailand;Spain;Israel;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04253236
(ClinicalTrials.gov)
August 11, 202021/1/2020To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic AnemiaDrug: RVT-1401 680 mg/weekly;Drug: RVT-1401 340 mg/weeklyImmunovant Sciences GmbHNULLRecruiting18 YearsN/AAll16Phase 2United States;Israel;Korea, Republic of;Spain;Thailand;United Kingdom
7EUCTR2019-001882-34-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
8NCT04039477
(ClinicalTrials.gov)
July 202026/7/2019A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITPA Phase 2 Randomized, Dose-blind, Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Autoimmune Hemolytic Anemia (AIHA) and Immune Thrombocytopenia (ITP)Autoimmune Hemolytic Anemia;Immune ThrombocytopeniaDrug: KZR-616Kezar Life Sciences, Inc.NULLWithdrawn18 YearsN/AAll0Phase 2United States;Australia;Italy;Poland;Russian Federation
9NCT04269551
(ClinicalTrials.gov)
June 15, 202029/1/2020A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin DiseaseA Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin DiseaseAutoimmune Haemolytic AnaemiaDrug: BIVV020SanofiNULLRecruiting18 YearsN/AAll18Phase 1United States;Canada;Germany;Norway;United Kingdom
10EUCTR2019-003924-19-ES
(EUCTR)
25/05/202014/01/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA Warm Autoimmune Hemolytic Anemia
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: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401
Immunovant Sciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United States;Hungary;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-004055-37-ES
(EUCTR)
06/05/202010/05/2020ALXN1830 in Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients with Warm 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 Code: ALXN1830
INN or Proposed INN: ORILANOLIMAB
Other descriptive name: SYNT001
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
32Phase 2United States;Taiwan;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of
12NCT04398459
(ClinicalTrials.gov)
May 1, 202018/5/2020The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic AnemiaA Phase II, Single-Center, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune HemolyticRefractory/Relapsed Autoimmune Hemolytic AnemiaDrug: IbrutinibInstitute of Hematology & Blood Diseases HospitalNULLRecruiting6 Years70 YearsAll18Phase 2China
13EUCTR2018-004774-97-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
14EUCTR2019-000720-17-NL
(EUCTR)
31/03/202016/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark;Germany;Netherlands;United Kingdom;Italy
15EUCTR2019-003924-19-GB
(EUCTR)
26/02/202013/03/2020Non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic AnemiaA Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients with Warm Autoimmune Hemolytic Anemia - ASCEND-WAIHA Warm Autoimmune Hemolytic Anemia
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: RVT-1401
Product Code: RVT-1401
INN or Proposed INN: RVT-1401
Other descriptive name: RVT-1401
Immunovant Sciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2United States;Thailand;Spain;Romania;Israel;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-001882-34-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
17NCT04119050
(ClinicalTrials.gov)
February 25, 202018/9/2019Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled StudyWarm Autoimmune Hemolytic AnemiaDrug: M281;Drug: PlaceboMomenta Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll90Phase 2;Phase 3United States;France;Germany;Hungary;Italy;Poland;Spain;Ukraine
18EUCTR2019-001882-34-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
19EUCTR2019-001882-34-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
20EUCTR2019-001882-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-001882-34-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
22EUCTR2019-000720-17-DE
(EUCTR)
14/01/202005/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
23EUCTR2019-000720-17-GR
(EUCTR)
27/12/201908/10/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2;Phase 3United States;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
24EUCTR2018-004774-97-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
25EUCTR2019-000720-17-HU
(EUCTR)
05/11/201906/11/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;United States;Czech Republic;Hungary;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04138927
(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
27EUCTR2018-004774-97-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
28EUCTR2018-004774-97-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
29EUCTR2019-000720-17-PL
(EUCTR)
09/10/201927/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
30EUCTR2018-004774-97-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
31EUCTR2018-004774-97-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
32EUCTR2019-000720-17-ES
(EUCTR)
19/09/201927/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
33EUCTR2019-000720-17-CZ
(EUCTR)
10/09/201910/09/2019Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic AnemiaEfficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
34EUCTR2018-004774-97-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
35EUCTR2018-004774-97-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-004774-97-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
37NCT03965624
(ClinicalTrials.gov)
September 1, 201924/5/2019Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune CytopeniaA Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune CytopeniaImmune Thrombocytopenia;Warm Autoimmune Hemolytic AnemiaDrug: NinlaroAssistance Publique - Hôpitaux de ParisTakeda Pharmaceuticals International, Inc.Withdrawn18 YearsN/AAll0Phase 2France
38NCT04083014
(ClinicalTrials.gov)
August 20, 201931/8/2019Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic AnemiaAn Open, One-arm, Prospective Study of a Single Dose Anti-CD20 Monoclonal Antibody Combined With Bortezomib for Treatment of Relapsed Refractory Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Anemia;Autoimmune Hemolytic Anemia and Autoimmune ThrombocytopeniaDrug: combination of a single dose anti-CD20 antibody and bortezomibPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll43Phase 2China
39EUCTR2018-004774-97-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
40ChiCTR1900023476
2019-07-012019-05-30Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemiaMulticenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia Autoimmune1:glucocorticoid;2:glucocorticoid & Ciclosporin;3:glucocorticoid & rapamycin;4:rapamycin;Tianjin Medical University General HospitalNULLPendingBoth1:20;2:20;3:20;4:20;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03918265
(ClinicalTrials.gov)
May 4, 201916/4/2019Tacrolimus Treatment for Refractory Autoimmune CytopeniaTacrolimus Treatment for Refractory Autoimmune CytopeniaAutoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans SyndromeDrug: TacrolimusPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll80Phase 4China
42NCT03764618
(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
43NCT04005638
(ClinicalTrials.gov)
February 2, 201917/6/2019Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune CytopeniaBiological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune CytopeniaImmune Thrombocytopenia;Autoimmune Hemolytic Anemia;Autoimmune NeutropeniaBiological: blood sample;Biological: urine sampleUniversity Hospital, BordeauxMinistry for Health and Solidarity, FranceRecruiting18 YearsN/AAll200France
44NCT03538041
(ClinicalTrials.gov)
November 21, 201815/5/2018A Study of INCB050465 in Participants With Autoimmune Hemolytic AnemiaA Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic AnemiaAutoimmune Hemolytic AnemiaDrug: ParsaclisibIncyte CorporationNULLRecruiting18 YearsN/AAll25Phase 2United States;Austria;France;Italy
45EUCTR2017-003538-10-NL
(EUCTR)
03/09/201818/12/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-003539-12-NL
(EUCTR)
03/09/201819/12/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand
47EUCTR2017-003652-22-AT
(EUCTR)
18/07/201829/03/2018A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (AIHA)A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia Autoimmune Hemolytic Anemia (AIHA), immunohemolytic anemia, autoimmune hemolytic anemia, immune complex hemolytic anemia. Warm AIHA, Cold AIHA
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]
Incyte CoorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
25Phase 2France;United States;Austria;Italy
48EUCTR2017-003363-35-IT
(EUCTR)
05/07/201804/11/2020Clinical study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD). - Treatment of wAIHA with APL-2 Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
MedDRA version: 20.0;Level: LLT;Classification code 10002045;Term: Anaemia haemolytic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: APL-2
Product Name: APL-2
Product Code: APL-2
INN or Proposed INN: APL-2
APELLIS PHARMACEUTCIALS, INC.NULLNot RecruitingFemale: yes
Male: yes
12Phase 2United States;Italy
49NCT03347422
(ClinicalTrials.gov)
March 17, 201816/11/2017A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood TransfusionA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Without a Recent History of Blood TransfusionCold Agglutinin DiseaseDrug: sutimlimab (BIVV009);Drug: placeboBioverativ, a Sanofi companyNULLActive, not recruiting18 YearsN/AAll40Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
50NCT03347396
(ClinicalTrials.gov)
March 5, 201816/11/2017A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood TransfusionAgglutinin Disease, ColdDrug: SutimlimabBioverativ, a Sanofi companyNULLActive, not recruiting18 YearsN/AAll20Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2017-003539-12-GB
(EUCTR)
26/02/201823/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand
52EUCTR2017-003538-10-GB
(EUCTR)
26/02/201823/10/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ a Sanofi Company Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Japan
53EUCTR2017-003538-10-DE
(EUCTR)
15/02/201830/10/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;New Zealand
54EUCTR2017-003539-12-DE
(EUCTR)
15/02/201830/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Japan;New Zealand
55EUCTR2017-003539-12-ES
(EUCTR)
06/02/201807/11/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR
Bioverativ USA Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2017-003538-10-BE
(EUCTR)
26/01/201806/12/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;New Zealand;Japan
57EUCTR2017-003539-12-BE
(EUCTR)
26/01/201806/12/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand
58EUCTR2017-003538-10-ES
(EUCTR)
19/01/201807/11/2017Open-Label with BIVV009 in patients with Cold Agglutinin Disease A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bioverativ USA Inc.NULLNot Recruiting Female: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan
59NCT03075878
(ClinicalTrials.gov)
January 10, 20183/3/2017A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)A Phase 1B/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Patients With Warm Autoimmune Hemolytic Anemia (WAIHA)Warm Autoimmune Hemolytic AnemiaDrug: ALXN1830Alexion PharmaceuticalsNULLTerminated18 YearsN/AAll8Phase 1;Phase 2United States;Jordan
60EUCTR2017-003538-10-AT
(EUCTR)
15/11/201710/10/2017Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THEEFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION - Cardinal Study Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2017-003539-12-AT
(EUCTR)
15/11/201710/10/2017A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusionsA PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION - Cadenza Primary Cold Agglutinin Disease
MedDRA version: 20.0;Level: PT;Classification code 10073785;Term: Autoimmune haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Product Name: BIVV009
Product Code: BIVV009
INN or Proposed INN: BIVV009
Other descriptive name: TNT009
Bioverativ USA, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand
62NCT03226678
(ClinicalTrials.gov)
August 31, 20177/7/2017Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)An Open Label, Prospective, Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)Warm Autoimmune Hemolytic Anemia;Cold Agglutinin DiseaseDrug: APL-2Apellis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll24Phase 2United States
63NCT02389231
(ClinicalTrials.gov)
May 17, 201713/2/2015Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment Anemil Trial : Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional TreatmentAutoimmune Hemolytic AnemiaDrug: Interleukine-2University Hospital, BordeauxNULLCompleted18 YearsN/AAll2Phase 1;Phase 2France
64NCT03827603
(ClinicalTrials.gov)
February 21, 201724/1/2019Ibrutinib in Steroid Refractory Autoimmune Hemolytic AnemiaIbrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment ApproachAIHA - Warm Autoimmune Hemolytic AnemiaDrug: IbrutinibEugene NikitinNULLActive, not recruiting18 YearsN/AAll50Phase 2Russian Federation
65NCT02612558
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02828670
(ClinicalTrials.gov)
June 7, 201623/6/2016Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)Autoimmune Hemolytic AnemiaBiological: blood sample;Procedure: spleen sampleCentre Hospitalier Universitaire DijonNULLRecruiting18 YearsN/AAll40France
67NCT02502903
(ClinicalTrials.gov)
July 13, 20157/7/2015Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated DisordersSafety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement-mediated Disorders. A Single/Multiple Ascending Dose Phase 1 Study.Bullous Pemphigoid (BP);Cold Agglutinin Disease (CAD);Warm Autoimmune Hemolytic Anemia (WAIHA);End-stage Renal Disease (ESRD)Drug: BIV009;Other: PlaceboBioverativ, a Sanofi companyCelerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics;Covance Laboratories - Chantilly;PPD Laboratories - Virginia;Softworld Inc. - Cambridge, MAActive, not recruiting18 YearsN/AAll122Phase 1Austria
68EUCTR2011-004835-30-FI
(EUCTR)
10/07/201317/06/2013Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Finland;Norway
69NCT02158195
(ClinicalTrials.gov)
July 20135/3/2014Immunopathology of Autoimmune Hemolytic AnemiaImmunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter StudyAutoimmune Hemolytic AnemiaBiological: blood samplesCentre Hospitalier Universitaire DijonNULLUnknown status16 YearsN/AAll24France
70EUCTR2012-003710-13-NL
(EUCTR)
21/03/201321/03/2013C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trialC1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune hemolytic anemia – an open-labeled pilot trial - C1-inhibitor improves efficacy of red blood cell transfusion in patients suffering from autoimmune h AutoImmune Hemolytic Anemia
MedDRA version: 15.1;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: CINRYZE® (C1 esterase inhibitor [human])Academic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-004835-30-DK
(EUCTR)
17/01/201330/11/2012Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Finland;Denmark;Norway
72NCT02689986
(ClinicalTrials.gov)
January 201316/2/2016Bendamustine and Rituximab Combination Therapy for Cold Agglutinin DiseaseThe CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination TherapyCold Agglutinin Disease;Autoimmune Hemolytic AnemiaDrug: Bendamustine, RituximabHelse FonnaNULLCompleted18 YearsN/AAll43Phase 2Denmark;Finland;Norway
73NCT01696474
(ClinicalTrials.gov)
December 201227/9/2012Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin DiseaseShort Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin DiseaseRefractory Cold Agglutinin DiseaseDrug: BortezomibGruppo Italiano Malattie EMatologiche dell'AdultoNULLCompleted18 YearsN/AAll21Phase 2Italy
74EUCTR2011-004835-30-NO
(EUCTR)
23/10/201229/08/2012Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy.Therapy for chronic cold agglutinin disease: A prospective,non-randomized international multicenter trial on the safetyand efficacy of bendamustine and rituximab combinationtherapy. - CAD5 Primary chronic cold agglutinin disease requiringtreatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Department of Medicine, Haugesund HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Norway
75EUCTR2011-006329-42-IT
(EUCTR)
11/10/201230/10/2012Short treatment with a drug for patients affected by a type of a treatment-resistant anaemia, where the red cells are destroyed by some cold cells (autoantibodies).Short course of Bortezomib in anemic patients with refractory cold agglutinin disease Anaemia with refractory cold agglutinin disease
MedDRA version: 14.1;Level: PT;Classification code 10009868;Term: Cold type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE*EV 1FL 3,5MG 1MG/MLG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTONULLNot RecruitingFemale: yes
Male: yes
25Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01579110
(ClinicalTrials.gov)
April 201213/4/2012Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.Anemia;Anemia, Hemolytic;Anemia, Hemolytic, Autoimmune;Hemolysis;Hematologic Diseases;Autoimmune Diseases;Immune System Diseases;Pathologic ProcessesDrug: levamisole;Drug: PrednisoneInstitute of Hematology & Blood Diseases HospitalNULLActive, not recruiting18 YearsN/ABoth100Phase 2China
77NCT01181154
(ClinicalTrials.gov)
March 3, 201112/8/2010Rituximab in Auto-Immune Hemolytic AnemiaRituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled TrialWarm Autoimmune Hemolytic AnemiaDrug: rituximab (Mabthera®);Drug: PlaceboAssistance Publique - Hôpitaux de ParisHoffmann-La RocheCompleted18 YearsN/AAll32Phase 3France
78NCT01303952
(ClinicalTrials.gov)
January 201124/2/2011Therapy of Chronic Cold Agglutinin Disease With EculizumabTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using EculizumabCold Agglutinin DiseaseDrug: EculizumabUniversity Hospital, EssenAlexion PharmaceuticalsCompleted18 YearsN/AAll13Phase 2Germany
79EUCTR2009-016966-97-DE
(EUCTR)
08/06/201008/02/2010Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE TrialTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized, Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients with Cold Agglutinin Disease Using Eculizumab - DECADE Trial Cold agglutinin disease
MedDRA version: 12.1;Level: LLT;Classification code 10009868;Term: Cold type haemolytic anaemia
Trade Name: Soliris (R)Universitätsklinikum EssenNULLNot RecruitingFemale: yes
Male: yes
Germany
80NCT00960713
(ClinicalTrials.gov)
June 200916/7/2009The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune DisordersThe RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune DisordersPemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;CryoglobulinemiaDrug: Rituximab (MABTHERA® or RITUXAN®).University Hospital, ToulouseNULLCompleted18 YearsN/ABoth35N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
82NCT01345708
(ClinicalTrials.gov)
January 200928/4/2011A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic AnemiaA Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic AnemiaAutoimmune Hemolytic Disease (Cold Type) (Warm Type)Drug: prednisone, low dose rituximabFondazione OspedaleUniversity Hospital, Udine, ItalyCompleted18 YearsN/ABoth23Phase 2Italy
83EUCTR2008-006713-25-IT
(EUCTR)
23/09/200816/01/2009A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - NDA SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHEINN or Proposed INN: RituximabOSPEDALE MAGGIORE DI MILANO (IRCCS)NULLNot RecruitingFemale: yes
Male: yes
Italy
84EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
85EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
87EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
88NCT00392951
(ClinicalTrials.gov)
December 200624/10/2006Sirolimus for Autoimmune Disease of Blood CellsSirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot SeriesAutoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid ArthritisDrug: sirolimusChildren's Hospital of PhiladelphiaNULLCompleted1 Year30 YearsAll30Phase 1;Phase 2United States
89NCT00373594
(ClinicalTrials.gov)
June 20057/9/2006Therapy for Chronic Cold Agglutinin DiseaseTherapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicentre Study on the Safety and Efficacy of Rituximab in Combination With Fludarabine.Cold Agglutinin DiseaseDrug: Rituximab;Drug: FludarabineUniversity of BergenNULLCompleted18 Years90 YearsBoth30Phase 2Norway;Russian Federation
90NCT01134432
(ClinicalTrials.gov)
March 200528/5/2010Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic AnemiaAnti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial.Anemia, Hemolytic, AutoimmuneDrug: prednisolone + mabthera;Drug: PrednisoloneCopenhagen University Hospital at HerlevNULLCompleted18 YearsN/ABoth65Phase 3Denmark