Prospective clinical study in children with severe haemophilia A to investigate clinical efficacy, immunogenicity, pharmacokinetics, and safety of Human-cl rhFVIII

Octapharma AG (Switzerland)0 个研究点目标入组 60 人开始时间: 2011年2月23日最近更新: 2018年1月8日

研究概览

暂无简介。

•1. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
•2. Previously treated with FVIII concentrate, at least 50 EDs
•3. Immunocompetent (CD4+ count above greater than 200/µL)
•4. Human immunodeficiency virus (HIV) negative or respective viral load less than 200 particles/µL or less than 400,000 copies/ml
•5. Freely given written informed consent by parents or legal guardian
•6. Aged between 2 and 12 years, males only

•1. Other coagulation disorder than haemophilia A
•2. Present or past FVIII inhibitor activity (greater than 0.6 BU)
•3. Target joints
•4. Severe liver or kidney disease (alanine aminotranferase [ALAT] and aspartate aminotransferase [ASAT] levels greater than 5 times of upper limit of normal, creatinine greater than 120 µmol/L)
•4. Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to greater than 10 mg/day), or similar drugs
•5. Current participation in another clinical study
•6. Participation in another interventional clinical study with administration of investigational medical product (IMP) in the course of the past 3 months, except studies investigating already registered FVIII products

发起方

Octapharma AG (Switzerland)