288. 自己免疫性後天性凝固因子欠乏症 Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details
臨床試験数 : 205 / 薬物数 : 238 - (DrugBank : 31) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 26
| 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 | NCT04567511 (ClinicalTrials.gov) | September 1, 2021 | 29/7/2020 | Hemlibra in Mild Hemophilia A | Prospective, Single-Arm, Open-Label Use of Hemlibra (Emicizumab) in the Treatment of Mild Hemophilia A | Factor VIII Deficiency, Congenital | Drug: Emicizumab | Indiana Hemophilia &Thrombosis Center, Inc. | Genentech, Inc. | Recruiting | 5 Years | 45 Years | Male | 40 | Phase 4 | United States |
| 2 | EUCTR2019-004430-42-AT (EUCTR) | 22/06/2021 | 22/04/2021 | Evaluation of the effect of emicizumab in patients suffering from acute bleeds with previously no family history. | Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial | Acquired Hemophilia A (AHA) MedDRA version: 22.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851 MedDRA version: 20.0;Classification code 10053760;Term: Acquired hemophilia;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Hemlibra® INN or Proposed INN: Emicizumab Other descriptive name: RO5534262 EMICIZUMAB | GWT-TUD GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 47 | Phase 2 | Austria;Germany | ||
| 3 | NCT04188639 (ClinicalTrials.gov) | March 23, 2021 | 4/12/2019 | Emicizumab in Acquired Hemophilia A | Emicizumab in Patients With Acquired Hemophilia A: Multicenter, Single-arm, Open-label Clinical Trial | Hemophilia A, Acquired | Drug: Emicizumab Injection | GWT-TUD GmbH | Hoffmann-La Roche;Hannover Medical School | Recruiting | 18 Years | N/A | All | 51 | Phase 2 | Austria;Germany |
| 4 | EUCTR2019-004430-42-DE (EUCTR) | 25/01/2021 | 20/11/2020 | Evaluation of the effect of emicizumab in patients suffering from acute bleeds with previously no family history. | Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial | Acquired Hemophilia A (AHA) MedDRA version: 22.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851 MedDRA version: 20.0;Classification code 10053760;Term: Acquired hemophilia;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Hemlibra® INN or Proposed INN: Emicizumab Other descriptive name: RO5534262 EMICIZUMAB | GWT-TUD GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 47 | Phase 2 | Austria;Germany | ||
| 5 | JPRN-JapicCTI-205151 | 15/6/2020 | 07/02/2020 | PHASE III STUDY OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A (AGEHA) | A MULTICENTER, OPEN-LABEL, NON-RANDOMIZED, PHASE III STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH ACQUIRED HEMOPHILIA A | Acquired hemophilia A | Intervention name : emicizumab (ACE910, RO5534262) INN of the intervention : emicizumab Dosage And administration of the intervention : Emicizumab will be administered subcutaneously once weekly. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Chugai Pharmaceutical Co., Ltd. | NULL | complete | 18 | BOTH | 11 | Phase 3 | Japan | |
| 6 | NCT04158648 (ClinicalTrials.gov) | February 10, 2020 | 7/11/2019 | A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors | A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors | Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor;Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor;Hemophilia A | Drug: Emicizumab | Hoffmann-La Roche | NULL | Active, not recruiting | N/A | N/A | All | 73 | Phase 3 | United States;Belgium;Canada;France;Germany;Netherlands;Poland;South Africa;Spain;United Kingdom;Italy |