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 | 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 | 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 | Factor 10 Deficiency | Drug: Coagadex | Bio Products Laboratory | NULL | Completed | 12 Years | N/A | All | 3 | United States | |
| 2 | 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 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 | Factor X Deficiency | Biological: FACTOR X | Bio Products Laboratory | NULL | Completed | N/A | 11 Years | All | 9 | Phase 3 | United Kingdom |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | 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 | 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 |
| 6 | 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 | ||
| 7 | 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 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 | 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 | Product Name: Recombinant factor XIII (rFXIII) Product Code: NN1841 INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | |||
| 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 of rFXIII in Paediatric (1 to less than 6 Years Old) Subjects with Congenital FXIII A-subunit Deficiency | 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 | Product Name: Recombinant factor XIII (rFXIII) Product Code: NN 1841 INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | 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 | United Kingdom | ||
| 9 | 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 | ||
| 10 | EUCTR2008-007883-41-AT (EUCTR) | 15/03/2010 | 25/01/2010 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 11 | 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 |
| 12 | 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 | ||
| 13 | 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 | |||
| 14 | EUCTR2008-007883-41-ES (EUCTR) | 16/11/2009 | 05/10/2009 | Ensayo multicéntrico, abierto, con un único brazo de tratamiento y dosis múltiples sobre la seguridad de la terapia sustitutiva mensual con factor XIII recombinante (rFXIII) en sujetos con deficiencia congénita de factor XIIIA Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Ensayo multicéntrico, abierto, con un único brazo de tratamiento y dosis múltiples sobre la seguridad de la terapia sustitutiva mensual con factor XIII recombinante (rFXIII) en sujetos con deficiencia congénita de factor XIIIA Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII DeficiencyDeficiencia congénita de factor XIII. MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 15 | EUCTR2009-010722-19-ES (EUCTR) | 04/11/2009 | 11/08/2009 | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congenital Factor XIII DeficiencyEstudio prospectivo, multicéntrico, con etiqueta abierta, en fase 3b, del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency | Trade Name: Fibrogammin® P Product Name: Factor XIII Concentrate (Human), Pasteurized INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized | CSL Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Spain | ||
| 16 | EUCTR2008-007883-41-GB (EUCTR) | 04/11/2009 | 23/07/2009 | 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 - Mentor™2 | 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 - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 17 | 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 | ||
| 18 | NCT00978380 (ClinicalTrials.gov) | September 21, 2009 | 15/9/2009 | Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 | 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 | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 6 Years | N/A | All | 63 | Phase 3 | United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom |
| 19 | NCT00945906 (ClinicalTrials.gov) | September 2009 | 23/7/2009 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) (FXIII) | CSL Behring | NULL | Completed | N/A | N/A | All | 61 | Phase 3 | United States |
| 20 | EUCTR2008-007883-41-FI (EUCTR) | 13/08/2009 | 15/06/2009 | 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 - Mentor™2 | 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 - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 21 | EUCTR2008-007883-41-FR (EUCTR) | 13/08/2009 | 05/08/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency(Safety Extension Trial to F13CD-1725) | Congenital Factor XIII Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 22 | EUCTR2008-007883-41-DE (EUCTR) | 04/08/2009 | 22/06/2009 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency - Mentor™2 | A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) inSubjects with Congenital Factor XIII Deficiency - Mentor™2 | Congenital Factor XIII Deficiency MedDRA version: 14.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors;Level: PT;Classification code 10061992;Term: Haemophilia;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Recombinant factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 23 | NCT00885742 (ClinicalTrials.gov) | August 2009 | 21/4/2009 | A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | NULL | Completed | N/A | N/A | All | 41 | Phase 3 | United States;Spain |
| 24 | EUCTR2009-010387-41-ES (EUCTR) | 25/06/2009 | 16/04/2009 | A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | A 12-week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects with Congential Factor XIII DeficiencyEstudio de 12 semanas, multicéntrico, de farmacocinética y seguridad del concentrado de factor XIII derivado del plasma humano en sujetos con deficiencia congénita de factor XIII | Congenital Factor XIII deficiencyDeficiencia congénita de factor XIII MedDRA version: 9.1;Level: LLT;Classification code 10016083;Term: Factor XIII deficiency | Trade Name: Fibrogammin®P Product Name: Factor XIII Concentrate (Human), Pasteurized INN or Proposed INN: Factor XIII Concentrate (Human), Pasteurized | CSL Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Spain | ||
| 25 | NCT00883090 (ClinicalTrials.gov) | May 2009 | 16/4/2009 | A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency | A 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Factor XIII Deficiency | Biological: FXIII Concentrate (Human) | CSL Behring | NULL | Completed | N/A | N/A | All | 15 | Phase 2 | United States;Spain |
| 26 | EUCTR2006-003148-51-FI (EUCTR) | 15/08/2008 | 24/06/2008 | 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 Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 27 | EUCTR2006-003148-51-GB (EUCTR) | 15/08/2008 | 09/05/2008 | 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 Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 28 | NCT00713648 (ClinicalTrials.gov) | August 2008 | 7/7/2008 | Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency | 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 | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 6 Years | N/A | All | 41 | Phase 3 | United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Spain;Switzerland;United Kingdom |
| 29 | EUCTR2006-003148-51-DE (EUCTR) | 29/07/2008 | 12/06/2008 | 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 Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 30 | EUCTR2006-003148-51-FR (EUCTR) | 22/07/2008 | 22/05/2008 | 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 Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | ||
| 31 | EUCTR2006-003148-51-AT (EUCTR) | 17/07/2008 | 16/06/2008 | 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 Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10010432;Term: Congenital deficiency of other clotting factors MedDRA version: 9.1;Classification code 10061992;Term: Haemophilia MedDRA version: 9.1;Level: HLT;Classification code 10009735;Term: Coagulation disorders congenital | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog Other descriptive name: Recombinant Factor XIII (rFXIII) | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 32 | 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 | |||
| 33 | NCT00056589 (ClinicalTrials.gov) | March 2003 | 18/3/2003 | Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency | A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency | Congenital Bleeding Disorder;Congenital FXIII Deficiency | Drug: catridecacog | Novo Nordisk A/S | NULL | Completed | 18 Years | N/A | All | 11 | Phase 1 | United States |
| 34 | NCT00640289 (ClinicalTrials.gov) | January 2000 | 17/3/2008 | Clinical Trial of Factor XIII (FXIII) Concentrate | Clinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII Deficiency | Hemophilia;Factor XIII Deficiency | Drug: Fibrogammin P | Children's Hospital of Orange County | CSL Behring | Completed | N/A | N/A | All | 72 | N/A | United States |
| 35 | EUCTR2014-003764-20-Outside-EU/EEA (EUCTR) | 11/03/2015 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | Congenital Factor XIII deficiency MedDRA version: 17.1;Level: PT;Classification code 10016083;Term: Factor XIII deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Cluvot INN or Proposed INN: Factor XIII Concentrate (Human) | CSL Behring LLC | NULL | NA | Female: yes Male: yes | 61 | United States |