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

  
11 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05221619
(ClinicalTrials.gov)
January 31, 20235/1/2022Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)Nipocalimab Post-trial Access in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA) Who Are Experiencing Clinical Benefit After Complete 28-Weeks Open-label Extension in MOM-M281-006Warm Autoimmune Hemolytic AnemiaDrug: NipocalimabJanssen Research & Development, LLCNULLTemporarily not availableN/AN/AAllNULL
2EUCTR2019-000720-17-NL
(EUCTR)
31/03/202016/09/2019Efficacy 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 Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Netherlands;Germany
3EUCTR2019-000720-17-DE
(EUCTR)
14/01/202005/09/2019Efficacy 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 Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
4EUCTR2019-000720-17-GR
(EUCTR)
27/12/201908/10/2019Efficacy 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 Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
5EUCTR2019-000720-17-HU
(EUCTR)
05/11/201906/11/2019Efficacy 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 Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10073784;Term: Anemia hemolytic autoimmune;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
6NCT04119050
(ClinicalTrials.gov)
October 24, 201918/9/2019Efficacy 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 Study With a Long-term Open-label ExtensionWarm Autoimmune Hemolytic AnemiaDrug: M281;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll111Phase 2/Phase 3United States;Brazil;Canada;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Spain;Ukraine;United Kingdom
7EUCTR2019-000720-17-FR
(EUCTR)
15/10/201917/09/2019Efficacy 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 Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3Netherlands;Germany;United Kingdom;Italy;United States;France;Hungary;Czech Republic;Greece;Spain;Poland;Denmark
8EUCTR2019-000720-17-PL
(EUCTR)
09/10/201927/09/2019Efficacy 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 Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: Not Applicable
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
9EUCTR2019-000720-17-ES
(EUCTR)
19/09/201927/09/2019Efficacy 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 Study Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;United States;Hungary;Czech Republic;Greece;Poland;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom
10EUCTR2019-000720-17-IT
(EUCTR)
16/09/201927/01/2021Efficacy 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 Study with a Long-term Open-label Extension - --- Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: M281
Product Code: [M281]
INN or Proposed INN: M281
Other descriptive name: M281
MOMENTA PHARMACEUTICALS, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Greece;Spain;Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands
11EUCTR2019-000720-17-CZ
(EUCTR)
10/09/201910/09/2019Efficacy 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 Study with a Long-term Open-label Extension Adults with Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.1;Level: LLT;Classification code 10002285;Term: Anemia hemolytic autoimmune (NOS);System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Product Name: Nipocalimab
Product Code: M281
INN or Proposed INN: N/A
Other descriptive name: Nipocalimab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
148Phase 2;Phase 3Ukraine;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Germany;Netherlands;United States;Czechia;Greece;Spain