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
Showing 1 to 10 of 36 diseases
| 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 | NCT03634215 (ClinicalTrials.gov) | August 15, 2018 | 1/7/2018 | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Traum ... | Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Traum ... | Multiple Trauma;Coagulation Disorder;Coagulation Factor Deficiency;Coagulation Defect; Acquired | Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity | Masaryk Hospital Krajská zdravotní a.s. | NULL | Unknown status | 18 Years | N/A | All | 200 | NULL | |
| 2 | NCT03161626 (ClinicalTrials.gov) | February 27, 2018 | 18/5/2017 | Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor XDeficiency Undergoin ... | A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patien ... | Factor 10 Deficiency | Drug: Coagadex | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | 3 | United States | |
| 3 | NCT01721681 (ClinicalTrials.gov) | April 2015 | 25/10/2012 | A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor Xin the Prophylaxis of Bleeding in ... | A Phase III Open, Multicentre Study to Investigate 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 A Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL' ... | Factor X Deficiency | Biological: FACTOR X | Bio Products Laboratory | NULL | Completed | N/A | 11 Years | All | 9 | Phase 3 | United Kingdom |
| 4 | 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. The purpose of this study is to look at how well FACTOR Xworks in preventing bleeding when taken reg ... | 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 A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s Hi ... | 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 Product Name: Human factor X Product Code: FACTOR X INN or Proposed INN: Human Coagulation Factor X Oth ... | Bio Products Laboratory Limited | NULL | Not Recruiting | Female: yes Male: yes | 8 | Phase 3 | Turkey;United Kingdom | ||
| 5 | 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. A study for people with coagulation factor Xdeficiency, to assess the effectiveness and safety of a ... | 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 Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Puri ... | 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 | ||
| 6 | NCT01086852 (ClinicalTrials.gov) | March 2011 | 10/11/2009 | Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing Surgery Safety & Efficacy of BPL's High Purity FACTOR Xin Treatment of Factor XDeficient Subjects Undergoing ... | A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL's High Purity FACTOR X in the Treatment of Factor X Deficient Subjects Undergoing Surgery A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL's High Purity FACT ... | Factor X Deficiency | Biological: FACTOR X | Bio Products Laboratory | NULL | Terminated | 12 Years | N/A | All | 4 | Phase 3 | United States;Spain;Turkey;United Kingdom;Germany |
| 7 | 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' ... | 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' ... | Factor X deficiency MedDRA version: 12.1;Level: LLT;Classification code 10052474;Term: Factor X deficiency Factor Xdeficiency MedDRA version: 12.1;Level: LLT;Classification code 10052474;Term: Factor Xdefici ... | 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 | ||
| 8 | EUCTR2009-016869-28-GB (EUCTR) | 20/09/2010 | 07/07/2010 | A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose ... | A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose ... | Congenital FXIII A-subunit Deficiency MedDRA version: 13.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders Congenital FXIII A-subunit Deficiency MedDRA version: 13.1;Level: PT;Classification code 10016083;Te ... | Product Name: Recombinant factor XIII (rFXIII) Product Code: NN 1841 INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) Product Name: Recombinant factor XIII (rFXIII) Product Code: NN 1841 INN or Proposed INN: Catridecacog ... | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | United Kingdom | ||
| 9 | EUCTR2010-020192-23-GB (EUCTR) | 20/09/2010 | 06/08/2010 | A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760 A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Effica ... | A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Paediatric Subjects with Congenital Factor XIII A-subunit Deficiency Safety Extension Trial to F13CD-3760 A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Effica ... | Congenital Factor XIII A-subunit Deficiency MedDRA version: 17.0;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders Congenital Factor XIII A-subunit Deficiency MedDRA version: 17.0;Level: PT;Classification code 10016 ... | Product Name: Recombinant factor XIII (rFXIII) Product Code: NN1841 INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) Product Name: Recombinant factor XIII (rFXIII) Product Code: NN1841 INN or Proposed INN: Catridecacog O ... | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 10 | 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. A study for people with coagulation factor Xdeficiency, to assess the effectiveness and safety of a ... | 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 Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Puri ... | 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 |