61. Autoimmune hemolytic anemia Clinical trials / Disease details
Clinical trials : 137 / Drugs : 127 - (DrugBank : 55) / Drug target genes : 26 - Drug target pathways : 153
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-003539-12-NL (EUCTR) | 03/09/2018 | 19/12/2017 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 2 | EUCTR2017-003539-12-IT (EUCTR) | 19/03/2018 | 15/01/2021 | A study to determine the safety and effectiveness of study drug BIVV009 in patients with Primary Agglutinin Disease without recent history of bloodtransfusions | 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 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | BIOVERATIV THERAPEUTICS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 3 | EUCTR2017-003538-10-IT (EUCTR) | 07/03/2018 | 28/01/2021 | 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 COLDAGGLUTININ 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 | BIOVERATIV THERAPEUTICS INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 4 | EUCTR2017-003538-10-GB (EUCTR) | 26/02/2018 | 23/10/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Japan | ||
| 5 | EUCTR2017-003539-12-GB (EUCTR) | 26/02/2018 | 23/10/2017 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 6 | EUCTR2017-003539-12-DE (EUCTR) | 15/02/2018 | 30/10/2017 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;Japan;New Zealand | ||
| 7 | EUCTR2017-003538-10-DE (EUCTR) | 15/02/2018 | 30/10/2017 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;New Zealand | ||
| 8 | EUCTR2017-003539-12-BE (EUCTR) | 26/01/2018 | 06/12/2017 | 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 INN or Proposed INN: BIVV009 Other descriptive name: TNT009 | Bioverativ USA, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | New Zealand;Japan;Norway;Germany;Netherlands;Australia;Belgium;Canada;France;United Kingdom;Italy;Israel;Austria;Spain;United States | ||
| 9 | EUCTR2017-003538-10-BE (EUCTR) | 26/01/2018 | 06/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand | ||
| 10 | EUCTR2017-003538-10-NO (EUCTR) | 18/12/2017 | 02/11/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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 a Sanofi Company Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Norway;Germany;Netherlands;Japan;New Zealand | ||
| 11 | EUCTR2017-003539-12-AT (EUCTR) | 15/11/2017 | 10/10/2017 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Norway;Japan;New Zealand | ||
| 12 | EUCTR2017-003538-10-AT (EUCTR) | 15/11/2017 | 10/10/2017 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Norway;Japan;New Zealand |