Catridecacog ( DrugBank: Catridecacog )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎4
288自己免疫性後天性凝固因子欠乏症16

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-001568-22-HU
(EUCTR)
15/01/201318/07/2012A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitisA 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/SNULLNot RecruitingFemale: yes
Male: yes
90Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation
2EUCTR2011-001568-22-BG
(EUCTR)
05/10/201216/08/2012A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitisA 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/SNULLNot RecruitingFemale: yes
Male: yes
90Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria
3NCT01706159
(ClinicalTrials.gov)
October 20129/10/2012A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative ColitisA Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative ColitisInflammation;Ulcerative ColitisDrug: catridecacog;Drug: placeboNovo Nordisk A/SNULLTerminated18 Years64 YearsAll20Phase 2Bulgaria;Croatia;Denmark;Hungary;Poland;Russian Federation;Ukraine
4EUCTR2011-001568-22-DK
(EUCTR)
23/08/201202/08/2012A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitisA 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/SNULLNot RecruitingFemale: yes
Male: yes
90Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation

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
1EUCTR2010-020192-23-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
2EUCTR2009-016869-28-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
3EUCTR2008-007883-41-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
4EUCTR2008-007883-41-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
5EUCTR2008-007883-41-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
6NCT00978380
(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
7EUCTR2008-007883-41-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
8EUCTR2008-007883-41-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
9EUCTR2008-007883-41-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
10EUCTR2006-003148-51-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
11EUCTR2006-003148-51-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
12NCT00713648
(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
13EUCTR2006-003148-51-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
14EUCTR2006-003148-51-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
15EUCTR2006-003148-51-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
16NCT00056589
(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