ISRCTN90038418CompletedNot Applicable
Clinical study to investigate the long-term safety and efficacy of human cell line recombinant Factor VIII (human-cl rhFVIII) in previously treated patients with severe haemophilia A
Octapharma AG (Switzerland)0 sites22 target enrollmentStarted: November 16, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
- •2. Aged greater than 18 years and less than 65 years, male only
- •3. Body weight 45 kg to 110 kg
- •4. Previously treated with human-cl rhFVIII (within study GENA-09)
- •6. Negative for human immunodeficiency virus (HIV) or respective viral load less than 200 particles/µL
- •7. Freely given written informed consent
Exclusion Criteria
- •1. Other coagulation disorder than haemophilia A
- •2. Present or past FVIII inhibitor activity (greater than 0.6 BU)
- •3. Severe liver or kidney disease (alanine aminotransferase [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. Participation in another clinical study currently or during the past month, except GENA-09
Investigators
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