To determine the pharmacokinetics of human-cl rhFVIII in terms of the FVIII coagulant activity (FVIII:C) and to compare it with the licensed FVIII concentrate Kogenate/Helixate in previously treated subjects suffering from severe hemophilia A.

• Conditions: Severe hemophilia A (FVIII:C <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: EUCTR2008-001563-11-BG
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-15
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

Must have severe hemophilia A (FVIII:C <1%).

Male subjects greater/equal 12 and less or equal than 65 years of age.

Body weight 25 kg to 110 kg.

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? no
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 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other coagulation disorder than hemophilia A.

Present or past FVIII inhibitor activity (>0.6 BU).

Severe liver or kidney disease (ALT and AST 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified