65. 原発性免疫不全症候群 Primary immunodeficiency Clinical trials / Disease details
臨床試験数 : 482 / 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
| 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 | EUCTR2011-004154-25-IT (EUCTR) | 25/06/2013 | 20/02/2013 | Clinical 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Egypt;Lebanon;Germany;Italy | ||
| 2 | EUCTR2007-004088-22-DE (EUCTR) | 14/04/2011 | 27/07/2010 | Efficacy 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 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 23 | Germany;Italy | |||
| 3 | EUCTR2006-006023-39-IT (EUCTR) | 24/09/2007 | 12/06/2007 | Pharmacokinetics of Haemocomplettan P in subjects with congenital fibrinogen deficiency - ND | Pharmacokinetics 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 P | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | Italy |