FACTOR X ( DrugBank: Factor X )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
288自己免疫性後天性凝固因子欠乏症35

288. 自己免疫性後天性凝固因子欠乏症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03161626
(ClinicalTrials.gov)
February 27, 201818/5/2017Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major SurgeryA Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major SurgeryFactor 10 DeficiencyDrug: CoagadexBio Products LaboratoryNULLCompleted12 YearsN/AAll3United States
2NCT01721681
(ClinicalTrials.gov)
April 201525/10/2012A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 YearsA 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 YearsFactor X DeficiencyBiological: FACTOR XBio Products LaboratoryNULLCompletedN/A11 YearsAll9Phase 3United Kingdom
3EUCTR2012-003093-98-GB
(EUCTR)
24/02/201502/01/2013The 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
8Phase 3Turkey;United Kingdom
4EUCTR2009-015086-31-ES
(EUCTR)
03/05/201227/02/2012A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
10Phase 3United States;Spain;Turkey;Germany;United Kingdom;India
5NCT01086852
(ClinicalTrials.gov)
March 201110/11/2009Safety & Efficacy of BPL's High Purity FACTOR X in Treatment of Factor X Deficient Subjects Undergoing SurgeryA 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 SurgeryFactor X DeficiencyBiological: FACTOR XBio Products LaboratoryNULLTerminated12 YearsN/AAll4Phase 3United States;Spain;Turkey;United Kingdom;Germany
6EUCTR2009-011145-18-DE
(EUCTR)
21/09/201001/04/2010A 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 deficiencyA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Spain;Germany;United Kingdom
7EUCTR2009-016869-28-GB
(EUCTR)
20/09/201007/07/2010A 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 DeficiencyA 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/SNULLNot 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): noUnited Kingdom
8EUCTR2010-020192-23-GB
(EUCTR)
20/09/201006/08/2010A 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-3760A 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/SNULLNot RecruitingFemale: yes
Male: yes
6France;Finland;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden
9EUCTR2009-015086-31-GB
(EUCTR)
16/03/201017/03/2010A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
10Phase 3United States;Spain;Turkey;Germany;United Kingdom;India
10EUCTR2008-007883-41-AT
(EUCTR)
15/03/201025/01/2010A 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/SNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;Italy;United Kingdom
11NCT00930176
(ClinicalTrials.gov)
January 201010/6/2009A Study Investigating Treatment Factor X in People With Factor X DeficiencyA 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 DeficiencyBiological: Human Coagulation FACTOR XBio Products LaboratoryNULLCompleted12 YearsN/AAll16Phase 3United States;Germany;Spain;Turkey;United Kingdom
12EUCTR2009-011145-18-ES
(EUCTR)
07/12/200902/10/2009A 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 deficiencyA 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 LaboratoryNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Spain;Germany;United Kingdom
13EUCTR2008-007883-41-IT
(EUCTR)
27/11/200931/12/2009A 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-3720A 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 NORDISKNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;United Kingdom;Italy
14EUCTR2008-007883-41-ES
(EUCTR)
16/11/200905/10/2009Ensayo 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/SNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;Italy;United Kingdom
15EUCTR2009-010722-19-ES
(EUCTR)
04/11/200911/08/2009A 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 XIIIA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Spain
16EUCTR2008-007883-41-GB
(EUCTR)
04/11/200923/07/2009 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/SNULLNot 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): noFrance;Finland;Spain;Austria;Germany;Italy;United Kingdom
17EUCTR2009-011145-18-GB
(EUCTR)
02/11/200924/09/2009A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
16Phase 3United States;Spain;Turkey;Germany;United Kingdom
18NCT00978380
(ClinicalTrials.gov)
September 21, 200915/9/2009Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725A 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 DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted6 YearsN/AAll63Phase 3United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Japan;Spain;Switzerland;United Kingdom
19NCT00945906
(ClinicalTrials.gov)
September 200923/7/2009An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open Enrollment Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human) (FXIII)CSL BehringNULLCompletedN/AN/AAll61Phase 3United States
20EUCTR2008-007883-41-FR
(EUCTR)
13/08/200905/08/2009A 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/SNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
21EUCTR2008-007883-41-FI
(EUCTR)
13/08/200915/06/2009A 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™2A 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/SNULLNot RecruitingFemale: yes
Male: yes
60France;Finland;Spain;Austria;Germany;Italy;United Kingdom
22EUCTR2008-007883-41-DE
(EUCTR)
04/08/200922/06/2009A 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™2A 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/SNULLNot RecruitingFemale: yes
Male: yes
60France;Finland;Spain;Austria;Germany;Italy;United Kingdom
23NCT00885742
(ClinicalTrials.gov)
August 200921/4/2009A Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA Prospective, Multicenter, Open-label, Phase 3b Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNULLCompletedN/AN/AAll41Phase 3United States;Spain
24EUCTR2009-010387-41-ES
(EUCTR)
25/06/200916/04/2009A 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 XIIIA 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 LLCNULLNot RecruitingFemale: yes
Male: yes
15Phase 2Spain
25NCT00883090
(ClinicalTrials.gov)
May 200916/4/2009A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII DeficiencyA 12 Week, Multicenter, Pharmacokinetic and Safety Study of Human Plasma-Derived Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyFactor XIII DeficiencyBiological: FXIII Concentrate (Human)CSL BehringNULLCompletedN/AN/AAll15Phase 2United States;Spain
26EUCTR2006-003148-51-FI
(EUCTR)
15/08/200824/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
27EUCTR2006-003148-51-GB
(EUCTR)
15/08/200809/05/2008A 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-1725A 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/SNULLNot 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): noFrance;Finland;Spain;Austria;Germany;Italy;United Kingdom
28NCT00713648
(ClinicalTrials.gov)
August 20087/7/2008Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited DeficiencyA 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 DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted6 YearsN/AAll41Phase 3United States;Austria;Canada;Finland;France;Germany;Israel;Italy;Spain;Switzerland;United Kingdom
29EUCTR2006-003148-51-DE
(EUCTR)
29/07/200812/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45France;Finland;Spain;Austria;Germany;Italy;United Kingdom
30EUCTR2006-003148-51-FR
(EUCTR)
22/07/200822/05/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Phase 3France;Finland;Spain;Austria;Germany;Italy;United Kingdom
31EUCTR2006-003148-51-AT
(EUCTR)
17/07/200816/06/2008A 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-1725A 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/SNULLNot RecruitingFemale: yes
Male: yes
45Finland;Germany;United Kingdom;France;Spain;Italy;Austria
32EUCTR2006-003148-51-IT
(EUCTR)
10/07/200823/09/2008A 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-1725A 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 NORDISKNULLNot RecruitingFemale: yes
Male: yes
40France;Finland;Spain;Austria;Germany;United Kingdom;Italy
33NCT00056589
(ClinicalTrials.gov)
March 200318/3/2003Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll DeficiencyA Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII DeficiencyCongenital Bleeding Disorder;Congenital FXIII DeficiencyDrug: catridecacogNovo Nordisk A/SNULLCompleted18 YearsN/AAll11Phase 1United States
34NCT00640289
(ClinicalTrials.gov)
January 200017/3/2008Clinical Trial of Factor XIII (FXIII) ConcentrateClinical Research Study of Factor XIII Concentrate From Human Plasma Fibrogammin P in Patients With Factor XIII DeficiencyHemophilia;Factor XIII DeficiencyDrug: Fibrogammin PChildren's Hospital of Orange CountyCSL BehringCompletedN/AN/AAll72N/AUnited States
35EUCTR2014-003764-20-Outside-EU/EEA
(EUCTR)
11/03/2015An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII DeficiencyA 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 LLCNULLNAFemale: yes
Male: yes
61United States