Phase IIIB, international, single group, open study to define an optimal monitor-ing of IGF-I in children treated with NutropinAq™, using a novel capillary blood collection method

Update Il y a 4 ans
Reference: EUCTR2004-000356-17

Woman and Man

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Extract

The number of capillary blood spot IGF-I measurements and the optimal timing of samples to assess the IGF-I status of NutropinAq treated patients.


Inclusion criteria

  • Children presenting growth failure associated with Growth Hormone Deficiency (GHD), Tuner Syndrome (TS) or Chronic Renal Insufficiency (CRI),NutropinAq(tm) is given as a daily subcutaneous injection dose: GDH: 0,025- 0,035 mg/kg/day, TS : up to 0,05 mg/kg/day, CRI : up to 0,05 mg/kg/day. No dose adaptation will be allowed during the study period unless tolerance or safety mandates a dose reduction