61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details
臨床試験数 : 146 / 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
| 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 | EUCTR2017-003538-10-NL (EUCTR) | 03/09/2018 | 18/12/2017 | Open-Label with BIVV009 in patients with Cold Agglutinin Disease | A 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. | 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 | ||
| 2 | EUCTR2017-003539-12-ES (EUCTR) | 06/02/2018 | 07/11/2017 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | 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 | ||
| 3 | EUCTR2017-003538-10-ES (EUCTR) | 19/01/2018 | 07/11/2017 | 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 INN or Proposed INN: BIVV009 Other descriptive name: COMPLEMENT C1 ESTERASE INHIBITOR | Bioverativ USA Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan |