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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04039477 | December 2019 | 11 November 2019 | A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA ITP | A 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 Thrombocytopenia | Drug: KZR-616 | Kezar Life Sciences, Inc. | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States | |
| 2 | NCT04119050 | October 2019 | 22 October 2019 | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia | Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study | Warm Autoimmune Hemolytic Anemia | Drug: M281;Drug: Placebo | Momenta Pharmaceuticals, Inc. | Recruiting | 18 Years | N/A | All | 90 | Phase 2/Phase 3 | United States | |
| 3 | NCT04138927 | October 2019 | 4 November 2019 | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: Fostamatinib disodium | Rigel Pharmaceuticals | Not recruiting | 18 Years | 100 Years | All | 80 | Phase 3 | ||
| 4 | NCT03965624 | September 1, 2019 | 4 November 2019 | Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia | A Prospective Open-label Trial to Assess the Efficacy and Safety of Ixazomib and Dexamethasone in Patients With Refractory Autoimmune Cytopenia | Immune Thrombocytopenia;Warm Autoimmune Hemolytic Anemia | Drug: Ninlaro | Assistance Publique - Hôpitaux de Paris | Takeda Pharmaceuticals International, Inc. | Not recruiting | 18 Years | N/A | All | 0 | Phase 2 | France |
| 5 | NCT04083014 | August 20, 2019 | 30 September 2019 | Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia | An Open, One-arm, Prospective Study of a Single Dose Anti-CD20 Monoclonal Antibody Combined With Bortezomib for Treatment of Relapsed Refractory Autoimmune Hemolytic Anemia | Autoimmune Hemolytic Anemia;Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia | Drug: combination of a single dose anti-CD20 antibody and bortezomib | Peking Union Medical College Hospital | Recruiting | 18 Years | 80 Years | All | 43 | Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | ChiCTR1900023476 | 2019-07-01 | 3 June 2019 | Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia | Multicenter, prospective and open clinical study for rapamycin in the treatment of autoimmune hemolytic anemia | Autoimmune | 1:glucocorticoid;2:glucocorticoid & Ciclosporin;3:glucocorticoid & rapamycin;4:rapamycin; | Tianjin Medical University General Hospital | Not Recruiting | Both | 1:20;2:20;3:20;4:20; | Phase 0 | China | |||
| 7 | NCT03918265 | April 10, 2019 | 29 April 2019 | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Autoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans Syndrome | Drug: Tacrolimus | Peking Union Medical College Hospital | Not recruiting | 18 Years | 80 Years | All | 80 | Phase 4 | China | |
| 8 | NCT03764618 | April 1, 2019 | 4 November 2019 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA | 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 | Drug: Fostamatinib disodium;Drug: Placebo | Rigel Pharmaceuticals | Recruiting | 18 Years | 100 Years | All | 80 | Phase 3 | United States;Australia;Georgia;Russian Federation | |
| 9 | NCT04005638 | February 2, 2019 | 15 July 2019 | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia | Immune Thrombocytopenia;Autoimmune Hemolytic Anemia;Autoimmune Neutropenia | Biological: blood sample;Biological: urine sample | University Hospital, Bordeaux | Ministry for Health and Solidarity, France | Recruiting | 18 Years | N/A | All | 200 | N/A | France |
| 10 | EUCTR2017-003652-22-AT | 18/07/2018 | 4 December 2018 | A 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] | 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 Coorporation | Authorised | Female: yes Male: yes | 20 | Phase 2 | France;United States;Austria;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2017-003538-10-DE | 15/02/2018 | 17 September 2018 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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 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 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. | Authorised | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Japan | |||
| 12 | EUCTR2017-003539-12-DE | 15/02/2018 | 1 October 2018 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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 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. | Authorised | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Japan | |||
| 13 | EUCTR2017-003539-12-ES | 06/02/2018 | 12 February 2018 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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 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. | Authorised | Female: yes Male: yes | 40 | Phase 3 | Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Japan;United States;Spain;Austria | |||
| 14 | EUCTR2017-003538-10-ES | 19/01/2018 | 28 February 2019 | Open-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] | 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 | 20 | Phase 3 | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan | |||
| 15 | NCT03075878 | January 10, 2018 | 30 September 2019 | A 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, Autoimmune | Drug: SYNT001 | Alexion Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 8 | Phase 1/Phase 2 | United States;Jordan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03347396 | November 20, 2017 | 29 July 2019 | A 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 Transfusion | Agglutinin Disease, Cold | Drug: Sutimlimab | Bioverativ Therapeutics Inc. | Not recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom | |
| 17 | NCT03347422 | November 20, 2017 | 22 October 2019 | A 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 Transfusion | Agglutinin Disease, Cold | Drug: Sutimlimab;Drug: Placebo | Bioverativ Therapeutics Inc. | Recruiting | 18 Years | N/A | All | 40 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Norway;Spain;United Kingdom | |
| 18 | EUCTR2017-003538-10-AT | 15/11/2017 | 12 November 2018 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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 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 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. | Authorised | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;New Zealand;Japan | |||
| 19 | EUCTR2017-003539-12-AT | 15/11/2017 | 12 November 2018 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of blood transfusions | A 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 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. | Authorised | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Norway;Germany;Japan;New Zealand | |||
| 20 | NCT03226678 | August 31, 2017 | 29 April 2019 | Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With wAIHA or 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 Disease | Drug: APL-2 | Apellis Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT02389231 | May 17, 2017 | 4 March 2019 | Evaluating 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 Treatment | Autoimmune Hemolytic Anemia | Drug: Interleukine-2 | University Hospital, Bordeaux | Not recruiting | 18 Years | N/A | All | 2 | Phase 1/Phase 2 | France | |
| 22 | NCT03827603 | February 21, 2017 | 11 February 2019 | Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia | Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia: ELaboration of Treatment Approach | AIHA - Warm Autoimmune Hemolytic Anemia | Drug: Ibrutinib | Eugene Nikitin | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | Russian Federation | |
| 23 | EUCTR2016-002478-11-AT | 19/07/2016 | 2 October 2017 | Very low doses of Rituximab for autoimmune diseases, for which rituximab is not approved for - a Pilot Trial | Very low doses of Rituximab for off-label treatment – a Pilot Trial - Low_Rituximab | Autoimmune-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 I | Authorised | Female: yes Male: yes | Phase 2 | Austria | ||||
| 24 | NCT02612558 | July 2016 | 30 September 2019 | A 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 Anemia | Warm Antibody Autoimmune Hemolytic Anemia | Drug: Fostamatinib 150 mg bid | Rigel Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 37 | Phase 2 | United States;Canada | |
| 25 | NCT02828670 | June 7, 2016 | 10 December 2018 | Role 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 Anemia | Biological: blood sample;Procedure: spleen sample | Centre Hospitalier Universitaire Dijon | Recruiting | 18 Years | N/A | All | 40 | Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT02502903 | June 2015 | 4 November 2019 | Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders | Safety, 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: Placebo | Bioverativ Therapeutics Inc. | Celerion Clinical Research GmbH;Assign Data Management and Biostatistics GmbH;ABF Pharmaceutical Services GmbH;Quest Diagnostics;Covance Laboratories - Chantilly | Recruiting | 18 Years | N/A | All | 122 | Phase 1 | Austria |
| 27 | NCT02158195 | July 2013 | 11 June 2018 | Immunopathology of Autoimmune Hemolytic Anemia | Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study | Autoimmune Hemolytic Anemia | Biological: blood samples | Centre Hospitalier Universitaire Dijon | Recruiting | 16 Years | N/A | All | 24 | Phase 4 | France | |
| 28 | EUCTR2012-003710-13-NL | 21/03/2013 | 19 August 2013 | C1-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 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]) Pharmaceutical Form: Concentrate and solvent for solution for infusion | Academic Medical Center | Authorised | Female: yes Male: yes | 10 | Netherlands | ||||
| 29 | NCT02689986 | January 2013 | 16 December 2017 | Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease | The 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 Therapy | Cold Agglutinin Disease;Autoimmune Hemolytic Anemia | Drug: Bendamustine, Rituximab | Helse Fonna | Not recruiting | 18 Years | N/A | All | 43 | Phase 2 | Denmark;Finland;Norway | |
| 30 | NCT01696474 | December 2012 | 16 December 2017 | Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease | Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease | Refractory Cold Agglutinin Disease | Drug: Bortezomib | Gruppo Italiano Malattie EMatologiche dell'Adulto | Not recruiting | 18 Years | N/A | All | 21 | Phase 2 | Italy | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2011-004835-30-NO | 23/10/2012 | 21 January 2013 | Therapy 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. - CAD5 | Primary 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 Hospital | Authorised | Female: yes Male: yes | 50 | Norway | ||||
| 32 | NCT01579110 | April 2012 | 19 February 2015 | Efficacy 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 Processes | Drug: levamisole;Drug: Prednisone | Institute of Hematology & Blood Diseases Hospital | Not recruiting | 18 Years | N/A | Both | 100 | Phase 2 | China | |
| 33 | NCT01181154 | March 3, 2011 | 16 December 2017 | Rituximab in Auto-Immune Hemolytic Anemia | Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial | Warm Autoimmune Hemolytic Anemia | Drug: rituximab (Mabthera®);Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Hoffmann-La Roche | Not recruiting | 18 Years | N/A | All | 32 | Phase 3 | France |
| 34 | EUCTR2009-016966-97-DE | 08/06/2010 | 19 January 2015 | Therapy 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 | Therapy 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) Pharmaceutical Form: Concentrate for solution for infusion | Universitätsklinikum Essen | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 35 | NCT00960713 | June 2009 | 19 February 2015 | The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders | The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders | Pemphigus;Auto-immune Thrombocytopenic Purpura;Hemolytic Auto-immune Anaemia;Cold Agglutinin Disease;Cryoglobulinemia | Drug: Rituximab (MABTHERA® or RITUXAN®). | University Hospital, Toulouse | Not recruiting | 18 Years | N/A | Both | 35 | N/A | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2008-006713-25-IT | 23/09/2008 | 19 March 2012 | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | A SINGLE-ARM PILOT STUDY WITH LOW-DOSE RITUXIMAB PLUS STANDARD ORAL PREDNISONE IN IDIOPATHIC AUTOIMMUNE HEMOLYTIC ANEMIA - ND | ANEMIE EMOLITICHE AUTOIMMUNI IDIOPATICHE | Pharmaceutical 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 Recruiting | Female: yes Male: yes | Italy | |||||
| 37 | EUCTR2007-001377-28-FR | 11/06/2008 | 19 March 2012 | Phase 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 | Phase 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 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. | Authorised | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | |||
| 38 | NCT00373594 | June 2005 | 19 February 2015 | Therapy for Chronic Cold Agglutinin Disease | Therapy 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 Disease | Drug: Rituximab;Drug: Fludarabine | University of Bergen | Not recruiting | 18 Years | 90 Years | Both | 30 | Phase 2 | Norway;Russian Federation | |
| 39 | NCT01134432 | March 2005 | 19 February 2015 | Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia | Anti-CD20 Antibody Rituximab in Addition to Prednisolone in Treatment of Warm Antibody Related Autoimmune Hemolytic Anemia. A Randomised Danish Multicenter Trial. | Anemia, Hemolytic, Autoimmune | Drug: prednisolone + mabthera;Drug: Prednisolone | Copenhagen University Hospital at Herlev | Not recruiting | 18 Years | N/A | Both | 65 | Phase 3 | Denmark | |
| 40 | NCT00309881 | April 2003 | 10 October 2016 | Combination 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 Leukemia | Biological: rituximab;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: prednisone;Drug: vincristine sulfate | German CLL Study Group | Not recruiting | 18 Years | N/A | Both | 75 | Phase 2 | Germany |