Clinical Study to Investigate the Efficacy, Safety, and Immunogenicityof human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Human-cl rhFVIII in Severe Haemophilia A (GENA-08)

Octapharma AG0 个研究点目标入组 32 人开始时间: 2010年7月13日最近更新: 2014年11月17日

试验速览

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•In order to qualify for study enrolment, each subject must satisfy the following criteria before
•study entry.
•1. Must have severe haemophilia A (FVIII:C less than or equal to 1%).
•2. Male subjects 12 years of age and above.
•3. Previously treated with FVIII concentrate, at least 150 EDs.
•4. Immunocompetent (CD4+ count above >200/µL).
•5. Negative for anti-HIV; if positive, respective viral load <200 particles/µL.
•6. 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 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Subjects will not be included if any of the following exclusion criteria are met.
•1. Other coagulation disorder than haemophilia A.
•2. Present or past FVIII inhibitor activity (greater than or equal to 0.6 BU).
•3. Severe liver or kidney disease (ALAT and ASAT levels >5 times of upper limit of normal, creatinine >120 µmol/L).
•4. 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.
•5. Participation in another interventional clinical study currently or during the past month.
•6. Participation in any other study with human-cl rhFVIII.

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