Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A
- Conditions
- Severe haemophilia A (FVIII:C <1%)
- Registration Number
- EUCTR2009-011055-43-AT
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 32
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method