EUCTR2011-002419-27-BG进行中（未招募）1 期
Prospective, open-label, uncontrolled, Phase III study to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in subjects with congenital fibrinogen deficiency. - Octafibrin in Congenital Fibrinogen Deficiency - FORMA-02
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria are eligible for the study:
- •1.Aged =12 years (only 18 and above in Russia)
- •2.Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis:
- •–Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia.
- •–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 planning to undergo elective surgery.
- •4.Informed consent signed by the subject or legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Subjects who meet any of the following criteria are not eligible for the study:
- •1.Life expectancy <6 months.
- •2.Bleeding disorder other than congenital fibrinogen deficiency, including dysfibrinogenaemia.
- •3.Prophylactic treatment with a fibrinogen concentrate.
- •4.Treatment with:
- •–Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the bleeding episode or surgery
- •–Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, warfarin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours (i.e., 1 day) after the last Octafibrin infusion.
- •5.Presence or history of:
- •–Hypersensitivity to study medication
- •–Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery
- •–Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery
- •–Hypersensitivity to human plasma proteins
- •–Oesophageal varicose bleeding
- •–End-stage liver disease (i.e., Child-Pugh score B or C).
- •6.Pregnant women within the first 20 weeks of gestation.
- •7.Currently breast-feeding.
- •8.Known positive HIV infection with a viral load >200 particles/µL or >400,000 copies/mL.
- •9.Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.
- •10.Diagnosis or suspicion of a neutralising anti-fibrinogen inhibitor currently or at any time in the past.
- •11.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, prednisone (equivalent to >10 mg/day), or similar drugs at study start
- •–Subjects having evidence or a history (within the previous 12 months) of abuse of any drug licit or illicit substance.
- •12.Participation in another interventional clinical study currently or during the past 4 weeks.
研究者
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