CTRI/2015/07/005953进行中（未招募）3 期
Prospective, open-label, uncontrolled, phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in paediatric subjects with congenital fibrinogen deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 4
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 (at the start of treatment). This will include two subgroups of subjects aged between 0 and <6 years and between 6 and <12 years of either gender.
- •2.Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis:
- •â?? Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrino-genaemia.
- •â?? Historical plasma fibrinogen activity of <50 mg/dL or levels below the limit of detection of the local assay method.
- •3.Expected to have an acute bleeding episode (spontaneous or after trauma) or plan-ning to undergo elective surgery.
- •4.Informed consent signed by the subjectâ??s legal guardian.
排除标准
- •1. Life expectancy <6 months.
- •2. Bleeding disorder other than congenital fibrinogen deficiency, including dysfi-brinogenaemia.
- •3. Prophylactic treatment with a fibrinogen concentrate.
- •4. Treatment with:
- •â?? Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the PK phase, a bleeding episode, or sur-gery.
- •â?? Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, war-farin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of the PK phase or treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours.
- •5. Presence or history of:
- •â?? Hypersensitivity to study medication.
- •â?? Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery.
- •â?? Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery
- •â?? Hypersensitivity to human plasma proteins.
- •â?? Oesophageal varicose bleeding.
- •â?? End-stage liver disease (i.e., Child-Pugh score B or C).
- •6. Known positive HIV infection with a viral load >200 particles/μL or >400,000 copies/mL.
- •7. Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.
- •8. Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or any time in the past.
- •9. Acute or chronic medical condition which may, in the opinion of investigator, affect the conduct of the study, including subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy), such as alpha-interferon, predni-sone (equivalent to >10 mg/day), or similar drugs, at study start.
- •10. Treatment with IMP in another interventional clinical study currently or during the past 4 weeks.
研究者
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