61. 自己免疫性溶血性貧血 Autoimmune hemolytic anemia Clinical trials / Disease details


臨床試験数 : 137 薬物数 : 139 - (DrugBank : 55) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 152

  
5 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04661033
(ClinicalTrials.gov)
September 9, 20211/12/2020Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic AnemiaWarm Autoimmune Hemolytic Anemia (wAIHA)Drug: Isatuximab SAR650984SanofiNULLRecruiting18 YearsN/AAll23Phase 1/Phase 2United States;Belgium;France;Germany;Hungary;Italy;Netherlands;United Kingdom
2EUCTR2020-003880-24-NL
(EUCTR)
09/06/202103/02/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy
3EUCTR2020-003880-24-IT
(EUCTR)
07/06/202104/06/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia - . Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Montelukast
Product Code: [.]
INN or Proposed INN: MONTELUKAST
Product Name: Isatuximab
Product Code: [SAR650984]
INN or Proposed INN: Isatuximab
Product Name: Paracetamolo
Product Code: [.]
INN or Proposed INN: PARACETAMOLO
Product Name: Famotidina
Product Code: [.]
INN or Proposed INN: FAMOTIDINA
Product Name: Levocitirizina
Product Code: [.]
INN or Proposed INN: LEVOCETIRIZINA DICLORIDRATO
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy
4EUCTR2020-003880-24-DE
(EUCTR)
24/03/202114/12/2020Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy
5EUCTR2020-003880-24-HU
(EUCTR)
18/03/202128/01/2021Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemiaA multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics,and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia Warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: PT;Classification code 10047822;Term: Warm type haemolytic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Isatuximab
Product Code: SAR650984
INN or Proposed INN: Isatuximab
Other descriptive name: SAR650984
Sanofi-Aventis Recherche & DeveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
23Phase 1;Phase 2France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy