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"
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003539-12-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
2EUCTR2017-003539-12-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
3EUCTR2017-003538-10-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
4EUCTR2017-003538-10-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
5EUCTR2017-003539-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-003538-10-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
7EUCTR2017-003539-12-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
8EUCTR2017-003539-12-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
9EUCTR2017-003538-10-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