Isatuximab ( DrugBank: Isatuximab )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 28 | 全身性アミロイドーシス | 3 |
| 61 | 自己免疫性溶血性貧血 | 5 |
| 283 | 後天性赤芽球癆 | 1 |
28. 全身性アミロイドーシス
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
| 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 | NCT05066607 (ClinicalTrials.gov) | February 11, 2022 | 24/8/2021 | Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy | A Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy | AL Amyloidosis | Drug: Isatuximab | Intergroupe Francophone du Myelome | Sanofi;Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 46 | Phase 2 | France |
| 2 | NCT04754945 (ClinicalTrials.gov) | April 28, 2021 | 9/2/2021 | Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis | Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy | AL Amyloidosis | Drug: Bortezomib;Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: Isatuximab | Emory University | Sanofi;National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 25 | Phase 1 | United States |
| 3 | NCT03499808 (ClinicalTrials.gov) | March 8, 2018 | 9/4/2018 | S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis | A Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL Amyloidosis | Amorphous, Eosinophilic, and Acellular Deposit;Constipation;Diarrhea;Early Satiety;Gastrointestinal Hemorrhage;Hepatomegaly;Lymphadenopathy;Macroglossia;Nausea;Primary Systemic Amyloidosis;Purpura;Recurrent Primary Amyloidosis;Refractory Primary Amyloidosis | Biological: Isatuximab;Other: Laboratory Biomarker Analysis | Southwest Oncology Group | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | N/A | All | 43 | Phase 2 | United States |
61. 自己免疫性溶血性貧血
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 |
283. 後天性赤芽球癆
臨床試験数 : 19 / 薬物数 : 36 - (DrugBank : 23) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
| 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 | NCT05559827 (ClinicalTrials.gov) | September 2022 | 14/9/2022 | Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation | Randomized Prospective Trial Evaluating the Efficacy of the antiCD38 Monoclonal Antibody Isatuximab in the Treatment of PCRA by Major ABO Mismatch After Allogeneic Hematopoietic Stem Cell Transplantation | Immunological Pure Red Cell Aplasia | Drug: Isatuximab | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 15 Years | N/A | All | 90 | Phase 2 | NULL |