Factor xiii (DrugBank: Factor XIII)
3 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 2 |
| 97 | 潰瘍性大腸炎 | 3 |
| 288 | 自己免疫性後天性凝固因子欠乏症［自己免疫性出血病XIII (~2017.3)］ | 26 |
| 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 | NCT02551042 (ClinicalTrials.gov) | September 2015 | 17/12/2014 | CSL Behring Sclero XIII | A Phase II, Double-blind, Randomized, Placebo-controlled Study to Investigate Pharmacokinetics (PK), Safety and Efficacy of Intravenous Factor XIII Treatment in Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Fibrogammin®P, coagulation factor XIII concentrate (Human);Drug: 0.9% sodium chloride | University College, London | CSL Behring | Recruiting | 18 Years | N/A | Both | 26 | Phase 2 | United Kingdom |
| 2 | EUCTR2014-001101-40-GB (EUCTR) | 24/02/2015 | 14/01/2015 | Investigation of safety and therapeutic effect of Fibrogammin® in Scleroderma | Sclero XIII: A phase II ,double-blind, randomized, placebo-controlled study to investigate pharmacokinetics (PK), safety and efficacy of intravenous factor XIII treatment in patients with systemic sclerosis - Sclero XIII | Systemic Sclerosis MedDRA version: 17.1;Level: LLT;Classification code 10010759;Term: Connective tissue disorder NOS;System Organ Class: 100000004859 MedDRA version: 17.1;Classification code 10018124;Term: Generalized scleroderma;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | University College London (UCL) | NULL | Not Recruiting | Female: yes Male: yes | 26 | Phase 2 | United Kingdom |
| 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 | EUCTR2011-001568-22-HU (EUCTR) | 15/01/2013 | 18/07/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation | |||
| 2 | EUCTR2011-001568-22-BG (EUCTR) | 05/10/2012 | 16/08/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria | |||
| 3 | EUCTR2011-001568-22-DK (EUCTR) | 23/08/2012 | 02/08/2012 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) INN or Proposed INN: Catridecacog | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation |
| 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 Trauma | 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 | 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 | 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 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 3 | United Kingdom | |||
| 4 | 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 | |||
| 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 | |||
| 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 |
| 6 | 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 | |||
| 7 | 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 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 8 | 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 3b | Spain | ||
| 9 | 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 |
| 10 | 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 |
| 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 |
| 11 | 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 | |||
| 12 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Finland;United Kingdom;Germany;France;Spain;Italy;Austria | |||
| 13 | 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 | |||
| 14 | 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 |
| 15 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Spain | |||
| 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 |
| 16 | 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 |
| 17 | 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 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 3 | France;Finland;Spain;Austria;Germany;Italy;United Kingdom | |||
| 18 | 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 | |||
| 19 | 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 |
| 20 | 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 | |||
| 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 |
| 21 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Finland;Germany;United Kingdom;France;Spain;Italy;Austria | |||
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 |
| 25 | 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 |
| 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 |
| 26 | 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 |