Severe hemophilia A (FVIII:C <1%)
Conditions
Interventions
Product Name: human-cl rhFVIII
Product Code: human-cl rhFVIII
Pharmaceutical Form: Powder and solvent for solution for infusion
Trade Name: Kogenate Bayer
Product Name: Kogenate
Product Code: Kogen
Sponsors
Octapharma AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Must have severe hemophilia A (FVIII:C 200/µL) Negative for anti-HIV; if positive, viral load =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To calculate the incremental recovery of FVIII:C for human-cl rhFVIII. To investigate the immunogenic potential of human-cl rhFVIII. To assess clinical efficacy and safety of human-cl rhFVIII in the treatment of bleeding episodes (BE). To assess clinical efficacy and safety of human-cl rhFVIII in surgical prophylaxis.;Primary end point(s): To compare the AUC of human-cl rhFVIII and Kogenate/Helixate for FVIII:C (normalized for the administered dose) using both the chromogenic (CHR) and the one-stage (OS) assay and the actual potency of human-cl rhFVIII and Kogenate/Helixate. | — |
Countries
Bulgaria, Germany
Outcome results
None listed