EUCTR2009-011055-43-AT进行中（未招募）不适用
Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- Male
入选标准
- •Severe haemophilia A (FVIII:C less/equal 1%).·
- •Male subjects greater/equal 12 years of age.·
- •Previously treated with FVIII concentrate, at least 150 EDs.·
- •Immunocompetent (CD4+ count >200/µL).·
- •Negative for anti-HIV; if positive, viral load <200 particles/µL or <400,000 copies/mL.
- •Freely given written informed consent.
- •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
排除标准
- •Other coagulation disorder than haemophilia A.·
- •Present or past FVIII inhibitor activity (>0.6 BU).·
- •Severe liver or kidney disease (ALAT and ASAT levels >5 times of upper limit of normal, creatinine >120 µmol/L).·
- •Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs.·
- •Participation in another interventional clinical study currently or during the past month. ·
- •Participation in any other study with human-cl rhFVIII.
研究者
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The main purpose of this study is to investigate the efficacy and safety of human-cl rhFVIII during prophylaxis but also if the patient needs treatment of spontaneous or traumatic bleeding episodes, and prior to and during or after surgery.EUCTR2009-011055-43-GBOctapharma AG32
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The main purpose of this study is to investigate the efficacy and safety of human-cl rhFVIII during prophylaxis but also if the patient needs treatment of spontaneous or traumatic bleeding episodes, and prior to and during or after surgery.Severe haemophilia A (FVIII:C <=1%)MedDRA version: 13.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2009-011055-43-DEOctapharma AG32
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