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 | NCT04661033 (ClinicalTrials.gov) | September 9, 2021 | 1/12/2020 | Safety, 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 Anemia | Warm Autoimmune Hemolytic Anemia (wAIHA) | Drug: Isatuximab SAR650984 | Sanofi | NULL | Active, not recruiting | 18 Years | N/A | All | 8 | Phase 1/Phase 2 | United States;Belgium;France;Germany;Hungary;Italy;Netherlands;United Kingdom |
| 2 | EUCTR2020-003880-24-NL (EUCTR) | 09/06/2021 | 03/02/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | 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 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 & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 3 | EUCTR2020-003880-24-IT (EUCTR) | 07/06/2021 | 04/06/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | 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 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 DEVELOPPEMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2020-003880-24-DE (EUCTR) | 24/03/2021 | 14/12/2020 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmunehemolytic anemia | 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 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 & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2020-003880-24-HU (EUCTR) | 18/03/2021 | 28/01/2021 | Safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia | 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 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 & Developpement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 1;Phase 2 | France;United States;Hungary;Belgium;Germany;Netherlands;United Kingdom;Italy |