DDrare: Database of Drug Development for Rare Diseases

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)］
［臨床試験数：189，薬物数：219（DrugBank：29），標的遺伝子数：18，標的パスウェイ数：26］

Searched query = "Autoimmune acquired coagulation factor deficiency", "Coagulation factor deficiency", "Factor XIII deficiency", "Factor VIII deficiency", "Acquired hemophilia A", "von Willebrand Disease", "Factor V deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ADVATE; ADVATE (rAHF - PFM); ADVATE (rAHF-PFM); ADVATE 1000 IU powder and solvent for solution for injection; ADVATE 1000IU powder and solvent for solution for injection; ADVATE 500 IU powder and solvent for solution for injection; ALPHANATE*INF 1F 1000UI+F 10ML; ALPHANATE*INF 1F 1500UI+F 10ML; ALPHANATE*INF 1F 250UI+F 5ML; ALPHANATE*INF 1F 500UI+F 5ML; APCC, aPCC + TXA; ARC 1779; ARC1779; ARC1779 Injection; Acetate; Advate; Alphanate; Alphanate 1000 I.U.; Alphanate 1500 I.U.; Alphanate SD/HT; Antihemophilic Factor (Recombinant); BAX 111; BAX111; BIVV001; BIVV001 (rFVIIIFc-VWF-XTEN); Biostate; Biostate®; Blood coagulation Factor VIII and vWF, human; Blood sample; Bortezomib; Catridecacog; Chloride; Cluvot; CoFactor; Coagulación factor VIII; Coagulation factor VIII; Coagulation factor XIII; Cyclophosphamide; DDAVP; DDAVP (Desmopressin); DESMOPRESSIN; Desmopressin; Desmopressin Acetate; Desmopressin acetate; Desmopressine; Device: Sublingual videomicroscopy; Diagnostic Test: blood sample , doppler of uterine vessel and placenta; Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity; Emicizumab; Emicizumab (ACE910, RO5534262); Emicizumab Injection; Eqwilate; F13CD; F8VR; FACTANE 200 IU/ml; FANHDI 100 UI; FANHDI 25 UI; FANHDI 250UI*1F 250UI+F 10ML; FANHDI 50 UI; FANHDI*INF FL 250UI+SIR SOLV+S; FANHDI*INF FL 500UI+SIR SOLV+S; FANHDI*INF FL1000UI+SIR SOLV+S; FANHDI*INF FL250UI+SIR SOLV+S; FXIII Concentrate (Human); FXIII Concentrate (Human) (FXIII); Factor VIII; Factor VIII concentrate; Factor XIII; Factor XIII Concentrate (Human); Factor XIII Concentrate (Human), Pasteurized; Factor von Willebrand; Fanhdi; Fanhdi 100 UI; Fanhdi 100 UI FVIII-120 UI FVW; Fanhdi 25 UI; Fanhdi 25 UI FVIII-30 UI FVW; Fanhdi 50 UI; Fanhdi 50 UI FVIII-60 UI FVW; Fibrinogen; Fibrogammin P; Fibrogammin® P; Fibrogammin®P; HEMOFIX; HUMAN COAGULATION FACTOR VIII; HUMAN COAGULATION FACTOR VIII, VON WILLEBRAND FACTOR COMPLEX; HUMAN VON WILLEBRAND FACTOR; Haemate P; Haemate P® (Human Coagulation Factor VIII); Haemate-P, Wilate; Haemate® P 250; Human Coagulation Factor VIII; Human Coagulation Factor VIII, Von Willebrand Factor Complex; Human VWF/FVIII concentrate; Human Von Willebrand Factor; Human coagulation Factor VIII / von Willebrand Factor; Human coagulation factor VIII; Human coagulation factor VIII associated with Von Willebrand factor (VWF); Human coagulation factor VIII associated with von Willebrand factor (VWF); Human von Willebrand Factor; Human von Willebrand factor; Human von Willebrand factor (VWF) and coagulation factor VIII (FVIII); Human von Willebrand factor (vWF) and coagulation factor VIII (FVIII); Human von willebrand factor; Humate-P; IL-11; Interleukin 11; Interleukin-11; Marketed plasma-derived VWF/FVIII concentrate; Minirin; Minrin; NN 1841; NN1841; Natriumchlorid; Natriumchlorid 0,9 %; Neumega (Oprelvekin, Interleukin 11, IL-11); OBI-1; OBIZUR; OCTANATE 100 UI/ml, poudre et solvant pour solution injectable; OCTANATE 50 UI/ml, poudre et solvant pour solution injectable; OCTOCOG ALFA; Obizur; Obyoctocog alfa; Octanate; Octocog alfa; Octostim; Oprelvekin; Oprelvekin, Interleukin 11, IL-11; Optivate; Optivate® (Human Coagulation Factor VIII); Other: Use of a postpartum diary and additional blood draws; Other: Use of a postpartum diary and additional blood draws.; Physiologische Kochsalzlösung Fresenius - Infusionslösung; Phytomenadione; Plasma-derived FVIII/VWF concentrate; Prednisone; Prothrombin; Prothrombin Complex Concentrate; Prothrombin complex concentrate; RAHF; RECOMBINANT HUMAN COAGULATION FACTOR VIII FC - VON WILLEBRAND FACTOR - XTEN FUSION PROTEIN; RFVIII; RFVIIa; RFVIIa, rFVIIa + TXA; RVWF; Recombinant Factor XIII; Recombinant Factor XIII (rFXIII); Recombinant Von Willebrand factor; Recombinant coagulation FVIII Fc – von Willebrand factor – XTEN fusion protein; Recombinant coagulation FVIII Fc – vonWillebrand factor – XTEN fusion protein; Recombinant factor VIIII (rFVIII); Recombinant factor XIII (rFXIII); Recombinant human von Willebrand Factor; Recombinant interleukin-11; Recombinant porcine coagulation factor VIII (B domain deleted); Recombinant porcine coagulation factor VIII (B-domain deleted); Recombinant von Willebrand Factor; Recombinant von Willebrand Factor (rVWF); Recombinant von Willebrand Factor 1300IU; Recombinant von Willebrand Factor 650IU; Recombinant von Willebrand factor; Recombinant von Willebrand factor (rVWF); Recombinant von Willebrand factor : recombinant FVIII (rVWF:rFVIII); Recomibnant human Von Willebrand Factor; Rituxan; Rituximab; Rurioctocog alfa pegol; SIMVASTATIN; SODIUM CHLORIDE SOLUTION 0.9%; Saline Solution; Simvastatin; Simvastatine; Sodium chloride; Standard of Care FVIII Replacement therapy; Standard of Care for Haemophilia A; Steroid; TAK-672; Tranexamic Acid; Tranexamic Acid Injection [Cyklokapron]; Tranexamic acid; Uterine; VEYONDI 650IU powder and solvent for solution for injection; VEYVONDI 1300IU powder and solvent for solution for injection; VEYVONDI 650IU powder and solvent for solution for injection; VON WILLEBRAND FACTOR; VONICOG ALFA; VWD factor VIII concentrate; VWF SD-35-DH; VWF replacement therapy with Wilate; VWF-containing products; VWF/FVIII products; Vessel; Von Willebrand Factor; Von Willebrand Factor Antigen; Von Willebrand Factor Ristocetin Cofactor; Von Willebrand Faktor; Von Willebrand factor; Von Willebrand factor (Recombinant); Von Willebrand factor and coagulation factor VIII in combination; Von willebrand factor; Voncento; Voncento, Biostate®; Voncento®; Vonicog Alfa; Vonicog alfa; WILATE; WILATE 1000 I.U.; WILATE 450; WILATE 500 I.U.; WILATE 900; WILATE® 450; WILFACTIN; Wilate; Wilate 1000; Wilate 1000 I.U.; Wilate 500; Wilate 500 I.U.; Wilfactin; Willfact; Wiloctin

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	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
2	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
3	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
4	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
5	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
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	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
7	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
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-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
10	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
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	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	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
13	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
14	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
15	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
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	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

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

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

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

France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden

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)

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

France;Finland;Spain;Austria;Germany;Italy;United Kingdom

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

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

France;Finland;Spain;Austria;Germany;United Kingdom;Italy

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)

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

France;Finland;Spain;Austria;Germany;Italy;United Kingdom

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

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

Phase 3

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

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

Phase 3

United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom

EUCTR2008-007883-41-FR
(EUCTR)

13/08/2009

05/08/2009

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

Finland;United Kingdom;Germany;France;Spain;Italy;Austria

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

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

France;Finland;Spain;Austria;Germany;Italy;United Kingdom

EUCTR2008-007883-41-DE
(EUCTR)

04/08/2009

22/06/2009

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

France;Finland;Spain;Austria;Germany;Italy;United Kingdom

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

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

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

EUCTR2006-003148-51-FI
(EUCTR)

15/08/2008

24/06/2008

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

Finland;Germany;United Kingdom;France;Spain;Italy;Austria

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

Phase 3

United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Spain;Switzerland;United Kingdom

EUCTR2006-003148-51-DE
(EUCTR)

29/07/2008

12/06/2008

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

France;Finland;Spain;Austria;Germany;Italy;United Kingdom

EUCTR2006-003148-51-FR
(EUCTR)

22/07/2008

22/05/2008

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

Finland;Germany;United Kingdom;France;Spain;Italy;Austria

EUCTR2006-003148-51-AT
(EUCTR)

17/07/2008

16/06/2008

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

Finland;Germany;United Kingdom;France;Spain;Italy;Austria

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

EUCTR2006-003148-51-IT
(EUCTR)

10/07/2008

23/09/2008

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

France;Finland;Spain;Austria;Germany;United Kingdom;Italy