Fibrinogen ( DrugBank: Fibrinogen )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー1
65原発性免疫不全症候群3

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03801135
(ClinicalTrials.gov)
October 3, 20184/10/2018Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate AnticoagulationA Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors ReplacementHumoral Rejection;Guillain-Barre Syndrome;Miller Fisher Syndrome;CIDP;Good Pasture Syndrome;Hyperviscosity SyndromeDrug: Fibrinogen concentrate;Other: Fresh Frozen PlasmaUniversity Medical Centre LjubljanaNULLRecruiting18 YearsN/AAll20N/ASlovenia

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004154-25-IT
(EUCTR)
25/06/201320/02/2013Clinical study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiencyA prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency Patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
MedDRA version: 14.1;Level: PT;Classification code 10016075;Term: Factor I deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Fibrinogen Concentrate from Human Plasma
Product Code: BT524
INN or Proposed INN: Human Fibrinogen Concentrate
Other descriptive name: Human Fibrinogen Concentrate
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 1;Phase 2Egypt;Lebanon;Germany;Italy
2EUCTR2007-004088-22-DE
(EUCTR)
14/04/201127/07/2010Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiencyFibrinogen Concentrate (Human) (FCH) - efficacy and safetyEfficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiencyFibrinogen Concentrate (Human) (FCH) - efficacy and safety Congenital fibrinogen deficiency (afibrinogenemia, severe hypofibrinogenemia)
MedDRA version: 12.0;Level: LLT;Classification code 10016075;Term: Factor I deficiency
Trade Name: Haemocomplettan(R) P 1g/2g
Product Name: Haemocomplettan(R) P
INN or Proposed INN: Fibrinogen (coagulation factorI)
Other descriptive name: HUMAN FIBRINOGEN
CSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
23Germany;Italy
3EUCTR2006-006023-39-IT
(EUCTR)
24/09/200712/06/2007Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - NDPharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND PK study in patient with afibrinogemia
MedDRA version: 9.1;Level: LLT;Classification code 10016075;Term: Factor I deficiency
Trade Name: Haemocomplettan PCSL Behring GmbHNULLNot RecruitingFemale: yes
Male: yes
Italy