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 61. 自己免疫性溶血性貧血 [臨床試験数:40,薬物数:51(DrugBank:22),標的遺伝子数:28,標的パスウェイ数:137] 

Searched query = "Autoimmune hemolytic anemia", "AIHA", "Cold agglutinin disease", "Paroxysmal cold hemoglobinuria"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04039477December 201911 November 2019A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA 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.Recruiting18 YearsN/AAll40Phase 2United States
2NCT04119050October 201922 October 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.Recruiting18 YearsN/AAll90Phase 2/Phase 3United States
3NCT04138927October 20194 November 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 PharmaceuticalsNot recruiting18 Years100 YearsAll80Phase 3
4NCT03965624September 1, 20194 November 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.Not recruiting18 YearsN/AAll0Phase 2France
5NCT04083014August 20, 201930 September 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 HospitalRecruiting18 Years80 YearsAll43Phase 2China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6ChiCTR19000234762019-07-013 June 2019Multicenter, 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 anemiaAutoimmune1:glucocorticoid;2:glucocorticoid & Ciclosporin;3:glucocorticoid & rapamycin;4:rapamycin;Tianjin Medical University General HospitalNot RecruitingBoth1:20;2:20;3:20;4:20;Phase 0China
7NCT03918265April 10, 201929 April 2019Tacrolimus Treatment for Refractory Autoimmune CytopeniaTacrolimus Treatment for Refractory Autoimmune CytopeniaAutoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans SyndromeDrug: TacrolimusPeking Union Medical College HospitalNot recruiting18 Years80 YearsAll80Phase 4China
8NCT03764618April 1, 20194 November 2019A 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 PharmaceuticalsRecruiting18 Years100 YearsAll80Phase 3United States;Australia;Georgia;Russian Federation
9NCT04005638February 2, 201915 July 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/AAll200N/AFrance
10EUCTR2017-003652-22-AT18/07/20184 December 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 AnemiaAutoimmune 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]
Product Code: INCB050465 1 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: not yet assigned
Current Sponsor code: INCB050465
Other descriptive name: INCB050465 HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Code: INCB050465 2.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: not yet assigned
Current Sponsor code: INCB050465
Other descriptive name: INCB050465 HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Incyte CoorporationAuthorisedFemale: yes
Male: yes
20Phase 2France;United States;Austria;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-003538-10-DE15/02/201817 September 2018Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, 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 StudyPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Bioverativ USA Inc.AuthorisedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Japan
12EUCTR2017-003539-12-DE15/02/20181 October 2018A 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 - CadenzaPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Bioverativ USA Inc.AuthorisedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Japan
13EUCTR2017-003539-12-ES06/02/201812 February 2018A 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 - CadenzaPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Bioverativ USA Inc.AuthorisedFemale: yes
Male: yes
40Phase 3Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria
14EUCTR2017-003538-10-ES19/01/201828 February 2019Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA 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 StudyPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Bioverativ USA Inc.Not 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
15NCT03075878January 10, 201830 September 2019A Safety Study of SYNT001 in Subjects With Warm Autoimmune Hemolytic Anemia (WAIHA)A Phase 1b/2, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects With Warm Autoimmune Hemolytic Anemia (WAIHA)Anemia, Hemolytic, AutoimmuneDrug: SYNT001Alexion PharmaceuticalsNot recruiting18 YearsN/AAll8Phase 1/Phase 2United States;Jordan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03347396November 20, 201729 July 2019A 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 Therapeutics Inc.Not recruiting18 YearsN/AAll20Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
17NCT03347422November 20, 201722 October 2019A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza Study)A 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 TransfusionAgglutinin Disease, ColdDrug: Sutimlimab;Drug: PlaceboBioverativ Therapeutics Inc.Recruiting18 YearsN/AAll40Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom
18EUCTR2017-003538-10-AT15/11/201712 November 2018Open-Label with BIVV009 in patients with Cold Agglutinin DiseaseA PHASE 3, 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 StudyPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Product Name: BIVV009
Product Code: BIVV009
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Bioverativ USA Inc.AuthorisedFemale: yes
Male: yes
20Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;New Zealand;Japan
19EUCTR2017-003539-12-AT15/11/201712 November 2018A 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 - CadenzaPrimary 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
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: BIVV009
Product Code: BIVV009
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: BIVV009
Current Sponsor code: BIVV009
Other descriptive name: TNT009
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Bioverativ USA Inc.AuthorisedFemale: yes
Male: yes
40Phase 3United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Norway;Germany;Japan;New Zealand
20NCT03226678August 31, 201729 April 2019Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With wAIHA or CADAn 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.Not recruiting18 YearsN/AAll24Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02389231May 17, 20174 March 2019Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional TreatmentAnemil 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, BordeauxNot recruiting18 YearsN/AAll2Phase 1/Phase 2France
22NCT03827603February 21, 201711 February 2019Ibrutinib in Steroid Refractory Autoimmune Hemolytic AnemiaIbrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment ApproachAIHA - Warm Autoimmune Hemolytic AnemiaDrug: IbrutinibEugene NikitinRecruiting18 YearsN/AAll50Phase 2Russian Federation
23EUCTR2016-002478-11-AT19/07/20162 October 2017Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot TrialVery low doses of Rituximab for off-label treatment – a Pilot Trial - Low_RituximabAutoimmune-haemolytic Anemia Antiphospholipid Syndrome Immune-mediated Thrombocytopenia
MedDRA version: 20.0 Level: LLT Classification code 10003825 Term: Autoimmune hemolytic anemia System Organ Class: 100000154058
MedDRA version: 20.0 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 100000157088
MedDRA version: 20.0 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Mabthera or biosimilar Rituximab
Product Name: Rituximab
Product Code: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: Rituximab
Other descriptive name: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Medical University of Vienna, Department of Internal medicine IAuthorisedFemale: yes
Male: yes
Phase 2Austria
24NCT02612558July 201630 September 2019A 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 PharmaceuticalsNot recruiting18 YearsN/AAll37Phase 2United States;Canada
25NCT02828670June 7, 201610 December 2018Role 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 DijonRecruiting18 YearsN/AAll40Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02502903June 20154 November 2019Safety, 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 Therapeutics Inc.Celerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics;Covance Laboratories - ChantillyRecruiting18 YearsN/AAll122Phase 1Austria
27NCT02158195July 201311 June 2018Immunopathology of Autoimmune Hemolytic AnemiaImmunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter StudyAutoimmune Hemolytic AnemiaBiological: blood samplesCentre Hospitalier Universitaire DijonRecruiting16 YearsN/AAll24Phase 4France
28EUCTR2012-003710-13-NL21/03/201319 August 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 hAutoImmune 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])
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Academic Medical CenterAuthorisedFemale: yes
Male: yes
10Netherlands
29NCT02689986January 201316 December 2017Bendamustine 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 FonnaNot recruiting18 YearsN/AAll43Phase 2Denmark;Finland;Norway
30NCT01696474December 201216 December 2017Short 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'AdultoNot recruiting18 YearsN/AAll21Phase 2Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-004835-30-NO23/10/201221 January 2013Therapy for chronic cold agglutinin disease: A prospective, non-randomized international multicenter trial on the safety and efficacy of bendamustine and rituximab combination therapy.Therapy for chronic cold agglutinin disease: A prospective, non-randomized international multicenter trial on the safety and efficacy of bendamustine and rituximab combination therapy. - CAD5Primary chronic cold agglutinin disease requiring treatment;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Levact
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE
CAS Number: 3543-75-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.5-
Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Department of Medicine, Haugesund HospitalAuthorisedFemale: yes
Male: yes
50Norway
32NCT01579110April 201219 February 2015Efficacy 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 HospitalNot recruiting18 YearsN/ABoth100Phase 2China
33NCT01181154March 3, 201116 December 2017Rituximab 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 RocheNot recruiting18 YearsN/AAll32Phase 3France
34EUCTR2009-016966-97-DE08/06/201019 January 2015Therapy 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 TrialCold agglutinin disease
MedDRA version: 12.1 Level: LLT Classification code 10009868 Term: Cold type haemolytic anaemia
Trade Name: Soliris (R)
Pharmaceutical Form: Concentrate for solution for infusion
Universitätsklinikum EssenNot RecruitingFemale: yes
Male: yes
Germany
35NCT00960713June 200919 February 2015The 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, ToulouseNot recruiting18 YearsN/ABoth35N/AFrance
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2008-006713-25-IT23/09/200819 March 2012A 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 - NDANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHEPharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
OSPEDALE MAGGIORE DI MILANO (IRCCS)Not RecruitingFemale: yes
Male: yes
Italy
37EUCTR2007-001377-28-FR11/06/200819 March 2012Phase 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™-TRAILAdult 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 newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis
MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis
MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis
MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Merck Serono International S.A.AuthorisedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
38NCT00373594June 200519 February 2015Therapy 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 BergenNot recruiting18 Years90 YearsBoth30Phase 2Norway;Russian Federation
39NCT01134432March 200519 February 2015Prednisolone +/- 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 HerlevNot recruiting18 YearsN/ABoth65Phase 3Denmark
40NCT00309881April 200310 October 2016Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia (CLL) That Did Not Respond to Fludarabine, CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)CHOP Plus Rituximab (CHOP-R) in Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL) or CLL With Autoimmune Haemolytic Anemia (AIHA) or Richter's Transformation (RT)Chronic Lymphocytic LeukemiaBiological: rituximab;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: prednisone;Drug: vincristine sulfateGerman CLL Study GroupNot recruiting18 YearsN/ABoth75Phase 2Germany

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