Physical Activity and FVIII Elimination: Relevance to Personalized Therapy in Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional

Summary: 
      In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic
      can vary according to determinants such as blood group, von Willebrand factor (VWF) level or
      age. However, FVIII pharmacokinetics (PK) has not been throughly studied in patients with
      severe HA as a function of daily physical activity. It si known that vigorous intensity
      physical activity/exercise can transiently but significantly increase circulating levels of
      endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or
      mild haemophilia A. The proposed study is a Proof of Concept one as it will be aimed at
      investigating the relation between daily physical activity, measured by Sensewear armband
      device, as number of daily steps and PK variability of infused rec-FVIII concentrate. This
      kind of investigation has never been done and it is a great interest also for the evaluation
      of patient's qualitiy of life.
    

Detailed description: 
      In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic
      can vary according to determinants such as blood group, von Willebrand factor (VWF) level or
      age. However, FVIII pharmacokinetics (PK) has not been throughly studied in patients with
      severe HA as a function of daily physical activity. It si known that vigorous intensity
      physical activity/exercise can transiently but significantly increase circulating levels of
      endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or
      mild haemophilia A. The proposed study is a Proof of Concept one as it will be aimed at
      investigating the relation between daily physical activity, measured by Sensewear armband
      device, as number of daily steps and PK variability of infused rec-FVIII concentrate. This
      kind of investigation has never been done and it is a great interest also for the evaluation
      of patient's qualitiy of life. Physical Examinations at screening and subsequent study visits
      a physical examination will be performed on the following body systems being described as
      normal or abnormal: general appearance, headand neck, eyes and ears, nose and throat, heart,
      abdomen, extremities and joints, lymph nodes and neurological. At screening, if an abnormal
      condition is detected, the condition will be described on the medical history CRF. At study
      visit, if a new abnormal or worsened abnormal pre-existing condition is detected, the
      condition will be described n the CRF.
    

Intervention name(s): SenseWear armband device
Intervention type(s): Device
Intervention description(s): Device: SenseWear armband device Metabolic Holter, Physical Activity and Lifestyle, Portable outpatient "multi-sensor" energy consumption in calories (EE), movement, physical activity, quality of life
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other