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

CSL Behring LLC0 个研究点目标入组 40 人开始时间: 2009年8月11日最近更新: 2012年6月26日

研究概览

暂无简介。

•1. Written informed consent/assent for study participation obtained before
•undergoing any study-specific procedures.
•2. Diagnosed with severe congenital FXIII deficiency (< 10 U/dL at time of initial
•diagnosis).
•3. Males and females of any age with congenital FXIII deficiency.
•4. Received full hepatitis B vaccination and/or is hepatitis B surface antibody positive.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Diagnosis of acquired FXIII deficiency.
•2. Administration of a FXIII-containing product, including blood transfusions or other
•blood products within 4 weeks prior to the planned Day 0.
•3. Any known congenital or acquired coagulation disorder other than congenital
•FXIII deficiency.
•4. Known or suspected to have antibodies towards FXIII.
•5. Use of any other investigational medicinal product within 4 weeks prior to the
•Baseline Visit (Day 0).
•6. Positive result for human immunodeficiency virus (HIV).
•7. Serum aspartate transaminase (AST) or serum alanine transaminase (ALT)
•concentration > 2.5 times the upper limit of normal at the Screening Visit of this
•study or at the Day 56 Visit of FXIII Study 2002.
•8. Fibrinogen level below the lower limit of normal at the Screening Visit of this
•study or the FXIII Study 2002.
•9. Active bleeding ? CTCAE Grade 2 and/or ? moderate (as defined in Section 8.2)
•between the Screening and Baseline Visits.
•10. Pregnant or breast-feeding.
•11. Intention to become pregnant during the course of the study.
•12. Female subjects of childbearing potential not using, or not willing to use, a
•medically reliable method of contraception for the entire duration of the study.
•13. Suspected inability (e.g., language problems) or unwillingness to comply with
•study procedures or history of noncompliance.

发起方