Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A.

• Conditions: Severe hemophilia A (FVIII:C <1%)

• Registration Number: EUCTR2008-001563-11-DE
• Lead Sponsor: Octapharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-18
• Last Update Posted: 28 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 25

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? 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) 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

Primary Outcome Measures

Name	Time	Method
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.<br>To investigate the immunogenic potential of human-cl rhFVIII.<br>To assess clinical efficacy and safety of human-cl rhFVIII in the treatment of bleeding episodes (BE).<br>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.