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 | 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 | ||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | |||
| 6 | 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 | ||
| 7 | 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 |
| 8 | 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 | |||
| 9 | 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 | ||
| 10 | 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 | |||
| 11 | 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 | |||
| 12 | 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 | ||
| 13 | 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 |
| 14 | 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 | |||
| 15 | 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 | ||
| 16 | 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 | |||
| 17 | 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 | |||
| 18 | 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 |