Coagulation factor X ( DrugBank: Coagulation factor X, 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7

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
1EUCTR2012-003093-98-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
2EUCTR2009-015086-31-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
3EUCTR2009-015086-31-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
4NCT00930176
(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
5EUCTR2008-007883-41-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
6EUCTR2009-011145-18-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
7EUCTR2006-003148-51-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