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.

Conditions: Severe haemophilia A (FVIII:C less than or equal to 1%)
MedDRA version: 14.0Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2009-011055-43-GB

Lead Sponsor: Octapharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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.