Factor xiii concentrate (human) (DrugBank: Factor XIII)
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[自己免疫性出血病XIII (~2017.3)] | 3 |
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 |
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1 | EUCTR2009-010722-19-ES (EUCTR) | 04/11/2009 | 11/08/2009 | A 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 | A 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 LLC | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3b | Spain | ||
2 | EUCTR2009-010387-41-ES (EUCTR) | 25/06/2009 | 16/04/2009 | A 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 | A 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 LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Spain | |||
3 | EUCTR2014-003764-20-Outside-EU/EEA (EUCTR) | 11/03/2015 | An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency | A 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 LLC | NULL | NA | Female: yes Male: yes | 61 | United States |