Saizen® in growth hormone deficiency (GHD) of adult onset

• Research type

  Research Study

• Full title

  Open-label, single-arm, phase IV, multicentre trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with growth hormone deficiency (GHD) of adult onset

• IRAS ID

  119181

• Contact name

  David Russell-Jones

• Sponsor organisation

  Merck KGaA

• Eudract number

  2012-004263-47

• ISRCTN Number

  N/A

• Research summary

  This is an open-label, single-arm, phase IV trial, conducted in adult participants with adult-onset (AO)-adult GHD (AGHD), who will be receiving Saizen© for 9 months, administered according to the local product label instructions. This treatment period will be preceded by a 6-week screening period, during which the participants’ eligibility will be assessed, and followed by a 2 week follow-up period off-treatment. The follow-up period will also allow for monitoring changes in BAbs or in IGF-I after treatment with Saizen© is stopped. Growth hormone deficiency in adults (AO-GHD) can be due to decreased hormone production (hypopituarism) either in childhood or developed in adulthood, tumours or following radiotherapy. Signs and symptoms of adults with GHD are changes in body composition (increased fat and reduced lean body mass), reduced physical performance, altered metabolism of fats, increased heart risk factors and reduced well-being. Growth hormone (GH) replacement therapy is beneficial in both the short and long term, and there have been numerous reviews on both the safety and effectiveness, and published studies of the effects of GH on body composition, bone metabolism, heart function and quality of life. Saizen© solution for injection is a recently approved treatment for growth hormone deficiency (GHD) in adults. Currently there is limited data available on the capacity of Saizen© solution for injection in provoking an immune system response (immunogenicity). Merck KGaA is sponsoring this study to record whether patients diagnosed with GHD in adulthood, develop antibodies to Saizen© solution for injection, and to what extent. In addition, this study will also measure adherence to treatment using the easypod™ auto-injector which can record the participants injection history. It is expected that 77 male and female adults from approximately 15 to 30 centres in Europe and Australia will take part in this study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  13/LO/0105

• Date of REC Opinion

  1 Mar 2013

• REC opinion

  Further Information Favourable Opinion