CTRI/2013/09/003953进行中（未招募）2 期
A Prospective, Controlled, Randomised, Cross-Over Study Investigating The Pharmacokinetic Properties, Surrogate Efficacy And Safety Of Octafibrin Compared To Haemocomplettan® P/ Riastap� In Subjects With Congenital Fibrinogen Deficiency. - RACE
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Aged >=12 years
- •2. Documented congenital fibrinogen deficiency (afibrinogenaemia)
- •a. Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. <20mg/dl)
- •3. Informed consent signed by subject or legal guardian
排除标准
- •1. Life expectancy <6 months
- •2. Bleeding disorder other than congenital fibrinogen deficiency
- •3. Dysfibrinogenemia
- •4. Treatment with:
- •a. Any fibrinogen concentrate or other fibrinogen-containing blood product in the 2 weeks prior to enrolment
- •5. Presence or history of:
- •a. Hypersensitivity to study medication
- •b. Deep vein thrombosis or pulmonary embolism within 1 year prior to enrolment
- •c. Arterial thrombosis within 1 year prior to enrolment
- •d. Hypersensitivity to human plasma proteins
- •6. Acute bleeding
- •7. History of oesophageal varicose bleeding
- •8. End-stage liver disease (i.e. Child-Pugh-score B or C)
- •9. Planned major surgery with a need for blood transfusion during the PK blood-sampling period of this study
- •10. Pregnancy, or the intention to become pregnant during the study
- •11. Currently breast-feeding, or with the intention of breast-feeding during the study
- •12. HIV positive with a viral load >200 particles/μl approximately >400000 copies/ml
- •13. Polytrauma 1 year prior to enrolment
- •14. Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery if available <0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors)
- •15. Blood or plasma donation in the 3 months prior to enrolment
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