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 | EUCTR2009-011145-18-DE (EUCTR) | 21/09/2010 | 01/04/2010 | 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 | 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: 12.1;Level: LLT;Classification code 10052474;Term: Factor X deficiency | Product Name: Human factor X Product Code: FACTOR X Other descriptive name: Human factor X | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | Spain;Germany;United Kingdom | ||
| 4 | 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 | ||
| 5 | EUCTR2009-011145-18-ES (EUCTR) | 07/12/2009 | 02/10/2009 | 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.Estudio de fase III, multicéntrico y abierto que investiga la farmacocinética, la seguridad y la eficacia del factor X de alta pureza de BPL en el tratamiento de la deficiencia del factor X grave y moderada. - A PK study of BPL's FX in patients with FX 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.Estudio de fase III, multicéntrico y abierto que investiga la farmacocinética, la seguridad y la eficacia del factor X de alta pureza de BPL en el tratamiento de la deficiencia del factor X grave y moderada. - A PK study of BPL's FX in patients with FX deficiency | Factor X deficiency.Deficiencia de Factor X MedDRA version: 12.0;Level: LLT;Classification code 10052474;Term: Factor X deficiency | Product Name: Human factor X Product Code: FACTOR X Other descriptive name: Human factor X | Bio Products Laboratory | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | Spain;Germany;United Kingdom | ||
| 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 |