Prospective clinical study in children with severe haemophilia A to investigate clinical efficacy, immunogenicity, pharmacokinetics, and safety of Human-cl rhFVIII

Octapharma AG (Switzerland)0 sites60 target enrollmentFebruary 23, 2011

Overview

No summary available.

Registry

who.int

Start Date

February 23, 2011

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional

Sex

Male

Sponsor

Octapharma AG (Switzerland)

•1\. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
•2\. Previously treated with FVIII concentrate, at least 50 EDs
•3\. Immunocompetent (CD4\+ count above greater than 200/µL)
•4\. Human immunodeficiency virus (HIV) negative or respective viral load less than 200 particles/µL or less than 400,000 copies/ml
•5\. Freely given written informed consent by parents or legal guardian
•6\. Aged between 2 and 12 years, males only

•1\. Other coagulation disorder than haemophilia A
•2\. Present or past FVIII inhibitor activity (greater than 0\.6 BU)
•3\. Target joints
•4\. Severe liver or kidney disease (alanine aminotranferase \[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\. Current participation in another clinical study
•6\. Participation in another interventional clinical study with administration of investigational medical product (IMP) in the course of the past 3 months, except studies investigating already registered FVIII products