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 : 206 / 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
| 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 | EUCTR2012-003093-98-GB (EUCTR) | 24/02/2015 | 02/01/2013 | The purpose of this study is to look at how well FACTOR X works in preventing bleeding when taken regularly in children aged under 12 years old, over a period of 6 months. The study will also look at how safe FACTOR X is by closely following the subjects progress during the study. | A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years | Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Human factor X Product Code: FACTOR X INN or Proposed INN: Human Coagulation Factor X Other descriptive name: FACTOR X | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 3 | Turkey;United Kingdom | ||
| 2 | EUCTR2009-015086-31-ES (EUCTR) | 03/05/2012 | 27/02/2012 | A study for people with coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate for people having surgery. | Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery | Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Human factor X Product Code: FACTOR X Other descriptive name: FACTOR X | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 3 | United States;Spain;Turkey;Germany;United Kingdom;India | ||
| 3 | EUCTR2009-015086-31-GB (EUCTR) | 16/03/2010 | 17/03/2010 | A study for people with coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate for people having surgery. | Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery | Factor X Deficiency;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Human factor X Product Code: FACTOR X Other descriptive name: FACTOR X | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 3 | United States;Spain;Turkey;Germany;United Kingdom;India | ||
| 4 | NCT00930176 (ClinicalTrials.gov) | January 2010 | 10/6/2009 | A Study Investigating Treatment Factor X in People With Factor X Deficiency | A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency. | Factor X Deficiency | Biological: Human Coagulation FACTOR X | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | 16 | Phase 3 | United States;Germany;Spain;Turkey;United Kingdom |
| 5 | EUCTR2008-007883-41-IT (EUCTR) | 27/11/2009 | 31/12/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-3720 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-3720 | Factor XIII Congenital deficiency. MedDRA version: 9.1;Level: HLGT;Classification code 10064477 MedDRA version: 9.1;Level: HLT;Classification code 10009737 MedDRA version: 9.1;Level: PT;Classification code 10016083 | Product Name: Recombinant Factor XIII INN or Proposed INN: Coagulation factor XIII | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;United Kingdom;Italy | |||
| 6 | EUCTR2009-011145-18-GB (EUCTR) | 02/11/2009 | 24/09/2009 | A study for people with severe and moderate coagulation factor X deficiency, to assess the effectiveness and safety of a high purity factor X concentrate, and how it is handled by the body. | A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency - A PK study of BPL's FX in patients with FX deficiency | Factor X deficiency MedDRA version: 14.1;Level: PT;Classification code 10052474;Term: Factor X deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Human factor X Product Code: FACTOR X INN or Proposed INN: Human coagulation Factor X Other descriptive name: Human factor X | Bio Products Laboratory Ltd | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | United States;Spain;Turkey;Germany;United Kingdom | ||
| 7 | EUCTR2006-003148-51-IT (EUCTR) | 10/07/2008 | 23/09/2008 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-1725 | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency. - F13CD-1725 | Congenital Factor XIII Deficency MedDRA version: 14.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10061992;Term: Haemophilia;Level: HLT;Classification code 10009737;Term: Coagulation factor deficiencies;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Recombinant Factor XIII Product Code: F13CD INN or Proposed INN: Coagulation factor XIII | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;United Kingdom;Italy |